DEVICE: TiMESH (04042301097606)

Device Identifier (DI) Information

TiMESH
6000312
In Commercial Distribution

pfm medical titanium gmbh
04042301097606
GS1

1
344675942 *Terms of Use
Ti-Mesh 6" X 6" Light 35g/m²
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Device Characteristics

Labeling does not contain MRI Safety Information
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?
59676 Pelvic organ prolapse surgical mesh, composite-polymer
A woven/knitted or porous material comprised of both a bioabsorbable polymer (e.g., poliglecaprone 25) and a non-bioabsorbable polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
FTL Mesh, Surgical, Polymeric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031225 000
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
No Device Sizes
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Device Record Status

fa606046-b360-42ee-9dfc-9d5425b02c82
November 14, 2022
3
June 02, 2020
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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
04042301097613 3 04042301097606 In Commercial Distribution Box
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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
No
No CLOSE

Customer Contact

[?]
7607588749
Regulatory@pfmmedicalusa.com
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