Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an endoscope, for diagnostic and/or operative endoscopy)Affected Serial Numbers: 90869KZD and 91114CADARTG Number: 233786
HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Nationwide. AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI
Descripción del producto
her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.
Worldwide Distribution - US (nationwide) and the country of S. Korea
Descripción del producto
seprafilm¿ Procedure Pack ADHESION BARRIER || Re-order Number: 5086-02 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Worldwide Distribution - US (nationwide) and the country of S. Korea
Descripción del producto
seprafilm¿ Single Site ADHESION BARRIER || Re-order Number: 6641-01 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
Descripción del producto
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 || Catalog Number: RFC2009 || Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
Descripción del producto
Boston Scientific HydroThermAblator Endometrial Ablation System- HTA¿ Procedure Set (5/bx) || Material/UPN/Catalog Number: M006550161 || Boston Scientific HydroThermAblator Endometrial Ablation System-HTA¿ Procedure Set (ea) || Material/UPN/Catalog Number: M006550160 || Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
Descripción del producto
Boston Scientific HydroThermAblator Endometrial Ablation System- || HTA¿ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx) || Material/UPN/Catalog Number: M006560201 || System-HTA¿ System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea) || Material/UPN/Catalog Number: M006560200 || Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
Worldwide Distribution - USA (nationwide) and the countries of Austria, Belgium, Brazil, Denmark, Canada, Cyprus, Finland, Germany, Hong Kong, India, Indonesia, Israel, Italy, Japan, Mexico, Netherlands, Norway, New Zealand, Panama, Portugal, Singapore, Sri Lanka, South Africa, Spain Thailand, Turkey, United Kingdom and Venezuela.
Descripción del producto
Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313). || Product Usage: || The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry.
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.
Descripción del producto
Milex Vaginal-Hymenal Silicone Dilators Set of 4 || P/N MX20 || Product Usage: || The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice
Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators || during gynecological laproscopic procedures || Model: Ally UPS