AccessGUDID - DEVICE: AMS 800 Urinary Control System Cuff with Inhibizone (00878953005652)

GUDID

Device Identifier (DI) Information

Brand Name: AMS 800 Urinary Control System Cuff with Inhibizone
Version or Model: 72015701
Catalog Number:
Company Name: AMERICAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00878953005652
Issuing Agency: GS1
Device Count: 1

Device Description: Cuff with InhibiZone, Length 3.5 cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Urethral sphincter prosthesis system	A sterile implantable assembly of devices indicated for incontinence and intended to support or replace a natural urethral sphincter. It is a hydraulically-operated system typically consisting of a single or double cuff to surround the urethra, a reservoir for the hydraulic liquid, e.g., saline with/without radiopacifier, and a manually driven pump. It is made of a non-bioabsorbable polymeric material.

GMDN Preferred Term Name

GMDN Definition

Urethral sphincter prosthesis system

A sterile implantable assembly of devices indicated for incontinence and intended to support or replace a natural urethral sphincter. It is a hydraulically-operated system typically consisting of a single or double cuff to surround the urethra, a reservoir for the hydraulic liquid, e.g., saline with/without radiopacifier, and a manually driven pump. It is made of a non-bioabsorbable polymeric material.

FDA Product Code

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

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 3.5 Centimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2014
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
HIBCC	H476720157011

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DEVICE: AMS 800 Urinary Control System Cuff with Inhibizone (00878953005652)