🚩 DEVICE: AMS 800 Artificial Urinary Sphincter (00878953000602)

Device Identifier (DI) Information

AMS 800 Artificial Urinary Sphincter
72400022
Not in Commercial Distribution

AMERICAN MEDICAL SYSTEMS, INC.
00878953000602
GS1
February 29, 2016
1
125111448 *Terms of Use
Pressure Regulating Balloon, Pressure: 41-50 cm H20
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
EZY Device, Incontinence, Mechanical/Hydraulic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 50 Centimeter
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Device Record Status

ec84568f-6453-4456-b76e-e3d377332280
August 16, 2023
6
September 24, 2014
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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