DEVICE: GYNECARE TVT (10705031062238)

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Device Identifier (DI) Information

GYNECARE TVT
810051
810051
Ethicon Sàrl
10705031062238
GS1
1
TVT Introducer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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

GMDN Preferred Term Name GMDN Definition
Female stress urinary incontinence surgical mesh A sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted to apply pressure to the urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). May be referred to as a sling or subfascial hammock, it may include an adjusting suture and be positioned with a transobturator needle. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
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FDA Product Code

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Product Code Product Code Name
KOA SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2015

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+1(877)384-4266
xxx@xxx.xxx
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