DEVICE: Conexa Reconstructive Tissue Matrix (M32805050030)

Device Identifier (DI) Information

Conexa Reconstructive Tissue Matrix
0505003
Not in Commercial Distribution
0505003
LIFECELL CORPORATION
M32805050030
HIBCC
July 31, 2018
1
157224205 *Terms of Use
Conexa 5cm x 5cm Thick Pliable Product, Rotator Cuff
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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?
60907 Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
FTL Mesh, Surgical, Polymeric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -8 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 5 Centimeter
Width: 5 Centimeter
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Device Record Status

50d37396-338a-4336-97b1-468b56e33bd2
October 04, 2023
5
September 17, 2015
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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
No Package DIs found
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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

[?]
800-367-5737
xx@xx.xx
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