AccessGUDID - DEVICE: VersaWrap Tendon Protector (B454VTP22011)

GUDID

Device Identifier (DI) Information

Brand Name: VersaWrap Tendon Protector
Version or Model: VTP2201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VTP2201
Company Name: Alafair Biosciences, Inc.

Primary DI Number: B454VTP22011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968882709 *Terms of Use

Device Description: VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. It is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap is a thin membrane of alginate and glycosaminoglycan and is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
35671	Tendon spacer	An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
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 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Inch
Width: 2 Inch
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: 81633b0e-b0b8-47ac-b474-2750e972b42f
Public Version Date: July 29, 2024
Public Version Number: 2
DI Record Publish Date: October 23, 2020