Coloplast Manufacturing US, LLC

4201931

General and Plastic Surgery Devices

1

No

US Distribution to MO and RI.

Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. || Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.

Lots 3390331, 3390339, 3390490.

General and Plastic Surgery Devices

2

Yes

US Distribution to: KY, MI, OH, PR, TX, and VA.

Digitex Absorbable Polydiaxanone Suture, Size 2-0. || Catalog Number / Code of product: 52031, 5203101400. || The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.

Lot numbers : 2936642, 2967400.

General and Plastic Surgery Devices

2

Yes

USA ( nationwide) including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, KY, MD, MS, MO, NY, PA, TN, VA,WA and WI.

Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark || Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including inguinal, fermoral, and incisional, and uterovaginal proplapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Item code Lot. No 1280801400 2460849 1280801400 2467727 1280801400 2478730 1280801400 2487494 1280801400 2642633 1280801400 2694739 1280801400 2881701 1280801400 2899205 1281001400 2286634 1281001400 2442838 1281001400 2460851 1281001400 2467729 1281001400 2478732 1281001400 2494667 1281001400 2504331 1281001400 2517312 1281001400 2528041 1281001400 2542226 1281001400 2581246 1281001400 2597087 1281001400 2717298 1281001400 2740701 1281001400 2801394 1281001400 2818921 1281001400 2835494 1281001400 2858099 1281001400 2881703 1281001400 2899207 1281801400 2494669 1281801400 2528043 1281801400 2589985 1281801400 2771851 1900101400 2744870 1900101400 2897575 1900101400 2910204 1900101400 2913671 1901001400 2785864 1901001400 2928713 1901101400 2785865 1901101400 2928714 1901101400 2932901

Gastroenterology-Urology Devices

1

No

Nationwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, GA, LA, MA, MD, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, and WI.

Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.) || Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2" -2 3/4"/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark. || These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.

2641603 2692541 2752163 2771698 2803598 2395370 2440555 2509063 2516364 2524050 2651814 2668369 2712685 2717532 2727614 2740196 2752164 2771659 2785552 2803602 2018979 2337367 2365131 2365132 2365134 2365135 2564957 2600245 2641600 2668412 2679492 2692543 2712686 2717531 2727613 2752165 2761468 2771696 2803595 2283082 2465091 2651905 2679493 2692545 2712687 2752166 2757289 2771701 2785553 2803599 2130238 2345466 2403178 2651870 2771700 2651868 2771695 2803600  2233842 2233842 2283075 2583200 2600244 2668374 2679497 2752168 2771692 2785551 2803601 2556881 2668363 2679495 2727615 2752169 2771694 2785548 2803597 2082467 2327518 2403253 2641601 2692542 2727612 2752170 2771697 2803596 2442703 2648503 2679494 2761467 2785554 2474786 2668366 2752167 2771702 1930978 2411690 2509038 2651872 2679496 2717533 2761247 2771691 2785550

Gastroenterology-Urology Devices

2

No

Nationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.

SpeediCath , SpeediCath with Accessories || Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark || 284821 1400 SpeediCath, acc CH10 Male || 284831 1400 SpeediCath, acc CH12 Male || 284841 1400 SpeediCath, acc CH14 Male || 284851 1400 SpeediCath, acc CH16 Male || 284861 1400 SpeediCath, acc CH18 Male || 284811 1400 SpeediCath, acc CH8 Male || 285011 1400 SpeediCath,acc CH10 Female || 285021 1400 SpeediCath,acc CH12 Female || 285031 1400 SpeediCath,acc CH14 Female || 285041 1400 SpeediCath,acc CH16 Female || 284991 1400 SpeediCath,acc CH6 Female || 285001 1400 SpeediCath,acc CH8 Female || The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with post void a residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urin to drain. The insertion supplies provided are to be used to insert the catheter using sterile technique.