AccessGUDID - DEVICE: AMS 800 Artificial Urinary Sphincter (00878953000602)

GUDID

Device Identifier (DI) Information

Brand Name: AMS 800 Artificial Urinary Sphincter
Version or Model: 72400022
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AMERICAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00878953000602
Issuing Agency: GS1
Commercial Distribution End Date: February 29, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 125111448 *Terms of Use

Device Description: Pressure Regulating Balloon, Pressure: 41-50 cm H20

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35280	Urethral sphincter prosthesis, non-powered	An implantable assembly of non-electric devices intended to support or replace a natural urethral sphincter for the management of incontinence. It is a hydraulically-operated system typically consisting of a cuff to surround the urethra, a reservoir for the hydraulic liquid (e.g., saline with/without radiopacifier), and a manually driven pump.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EZY	Device, Incontinence, Mechanical/Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 50 Centimeter

Device Record Status

Public Device Record Key: ec84568f-6453-4456-b76e-e3d377332280
Public Version Date: August 16, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2014