DEVICE: TenoWrap (00813954025735)

Device Identifier (DI) Information

TenoWrap
ABS-16025
In Commercial Distribution
ABS-16025
COLLAGEN MATRIX, INC.
00813954025735
GS1

1
176262442 *Terms of Use
Collagen Tendon Wrap
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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?
43233 Nerve guide, animal-derived
An implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is intended to be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
FTM Mesh, Surgical
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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 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 16.0 mm ID x 2.5 cm length
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Device Record Status

9f037c39-8184-4ff7-80d5-0cb747b171e7
March 05, 2024
3
July 14, 2023
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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) 934-4404
Customer_Service@Arthrex.com
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