AccessGUDID - DEVICE: TenoWrap (00813954025735)

GUDID

Device Identifier (DI) Information

Brand Name: TenoWrap
Version or Model: ABS-16025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABS-16025
Company Name: COLLAGEN MATRIX, INC.

Primary DI Number: 00813954025735
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176262442 *Terms of Use

Device Description: Collagen Tendon Wrap

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
FTM	Mesh, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16.0 mm ID x 2.5 cm length

Device Record Status

Public Device Record Key: 9f037c39-8184-4ff7-80d5-0cb747b171e7
Public Version Date: March 05, 2024
Public Version Number: 3
DI Record Publish Date: July 14, 2023

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

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (800) 934-4404
Email: Customer_Service@Arthrex.com

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