VersaWrap Tendon Protector VTP2201

GUDID B454VTP22010

VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been no substantial loss of

ALAFAIR BIOSCIENCES, INC

Tendon spacer

Primary Device ID	B454VTP22010
NIH Device Record Key	ceb7320b-f9ad-421c-b3e8-acb3eb84b3c4
Commercial Distribution Status	In Commercial Distribution
Brand Name	VersaWrap Tendon Protector
Version Model Number	VTP2201
Catalog Number	VTP2201
Company DUNS	968882709
Company Name	ALAFAIR BIOSCIENCES, INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter
Total Volume	1 Milliliter
Length	2 Inch
Width	2 Inch
Length	5 Centimeter
Width	5 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B454VTP22010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160364

FDA Product Code

JXI	Cuff, Nerve
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-12-15

On-Brand Devices [VersaWrap Tendon Protector]

B454VTP22010	VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon in
B454VTP12011	VersaWrap Tendon Protector (K200311) is indicated for the management and protection of tendon in
B454VTP22011	VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon in