DEVICE: SURGIMESH®WN (03700296900554)
Device Identifier (DI) Information
SURGIMESH®WN
T613-8
In Commercial Distribution
T613-8
ASPIDE MEDICAL
T613-8
In Commercial Distribution
T613-8
ASPIDE MEDICAL
Non woven, non knitted reinforcement material made from polypropylene.
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? |
---|---|---|---|---|
60300 | Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable |
An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FTL | Mesh, Surgical, Polymeric |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Keep away from sunlight |
Special Storage Condition, Specify: Store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 1/2 OVALE 6x13cm |
Device Record Status
286f7e09-743e-400e-9869-4bcb15102902
June 10, 2022
7
October 23, 2015
June 10, 2022
7
October 23, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
03700296903678 | 5 | 03700296900554 | 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
[?]
No Customer Contact currently defined