DEVICE: TiMESH (04042301097606)
Device Identifier (DI) Information
TiMESH
6000312
In Commercial Distribution
pfm medical titanium gmbh
6000312
In Commercial Distribution
pfm medical titanium gmbh
Ti-Mesh 6" X 6" Light 35g/m²
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OXJ | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects |
FTL | Mesh, Surgical, Polymeric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K031225 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fa606046-b360-42ee-9dfc-9d5425b02c82
November 14, 2022
3
June 02, 2020
November 14, 2022
3
June 02, 2020
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 |
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
[?]
7607588749
Regulatory@pfmmedicalusa.com
Regulatory@pfmmedicalusa.com