DEVICE: AMS 800 Artificial Urinary Sphincter (00878953005652)
Device Identifier (DI) Information
AMS 800 Artificial Urinary Sphincter
720157-01
In Commercial Distribution
720157-01
BOSTON SCIENTIFIC CORPORATION
720157-01
In Commercial Distribution
720157-01
BOSTON SCIENTIFIC CORPORATION
Occlusive Cuff with InhibiZone
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EZY | Device, Incontinence, Mechanical/Hydraulic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P000053 | 024 |
P000053 | 041 |
P000053 | 047 |
P000053 | 050 |
P000053 | 053 |
P000053 | 054 |
P000053 | 065 |
P000053 | 067 |
P000053 | 075 |
P000053 | 083 |
P000053 | 095 |
P000053 | 096 |
P000053 | 103 |
P000053 | 104 |
P000053 | 105 |
P000053 | 112 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 3.5 Centimeter |
Device Record Status
f2907a76-c8cf-4447-af06-31559e6717c4
September 23, 2024
8
September 24, 2014
September 23, 2024
8
September 24, 2014
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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined