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

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Device Identifier (DI) Information

AMS 800 Urinary Control System Cuff with Inhibizone
72015701

AMERICAN MEDICAL SYSTEMS, INC.
00878953005652
GS1
1
Cuff with InhibiZone, Length 3.5 cm
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
Yes
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.
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FDA Product Code

[?]
Product Code Product Code Name
EZY Device, Incontinence, Mechanical/Hydraulic
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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: 3.5 Centimeter
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Device Status

In Commercial Distribution
September 24, 2014

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
HIBCC H476720157011
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Unit of Use DI

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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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