AccessGUDID - DEVICE: AMS 800 Artificial Urinary Sphincter (00878953000633)

GUDID

Device Identifier (DI) Information

Brand Name: AMS 800 Artificial Urinary Sphincter
Version or Model: 72400025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72400025
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00878953000633
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Pressure Regulating Balloon

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 [?]
P000053	000
P000053	003
P000053	040
P000053	047
P000053	050
P000053	065
P000053	067
P000053	083
P000053	096
P000053	103
P000053	112

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
Device Size Text, specify: 71-80 cmH2O Pressure

Device Record Status

Public Device Record Key: 7bb7fb9d-6763-44f9-a3ad-4aed0af817d7
Public Version Date: September 12, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2014