VersaWrap VTP-1201

GUDID B454VTP12010

VersaWrap is an absorbable implant device that provides a non-constricting encasement for injured tendon and/or injured peripheral nerves. VersaWrap consists of a sheet and a wetting solution. The sheet is an ultrathin alginate / glycosaminoglycan hydrogel that is easy to handle, non-sided, conformable, and designed for easy placement under, around, or over injured tissue. After positioning the sheet onto damaged tissue, the VersaWrap wetting solution (an aqueous chelator) is applied to quickly transition the sheet into a bioresorbable, gelatinous interface.

ALAFAIR BIOSCIENCES, INC

Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer Tendon spacer
Primary Device IDB454VTP12010
NIH Device Record Key0d3ba45f-eb72-436e-abb9-a60207faab7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaWrap
Version Model NumberVTP-1201
Catalog NumberVTP-1201
Company DUNS968882709
Company NameALAFAIR BIOSCIENCES, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length1 Inch
Width2 Inch
Total Volume1 Milliliter
Length1 Inch
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Total Volume1 Milliliter
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Total Volume1 Milliliter
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Total Volume1 Milliliter
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Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB454VTP12010 [Primary]

FDA Product Code

JXICuff, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-11-01

Devices Manufactured by ALAFAIR BIOSCIENCES, INC

B454VTP12010 - VersaWrap2020-11-09VersaWrap is an absorbable implant device that provides a non-constricting encasement for injured tendon and/or injured peripheral nerves. VersaWrap consists of a sheet and a wetting solution. The sheet is an ultrathin alginate / glycosaminoglycan hydrogel that is easy to handle, non-sided, conformable, and designed for easy placement under, around, or over injured tissue. After positioning the sheet onto damaged tissue, the VersaWrap wetting solution (an aqueous chelator) is applied to quickly transition the sheet into a bioresorbable, gelatinous interface.
B454VTP12010 - VersaWrap2020-11-09 VersaWrap is an absorbable implant device that provides a non-constricting encasement for injured tendon and/or injured peripher
B454VTP22011 - VersaWrap Tendon Protector2020-11-02 VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been n
B454VTP12011 - VersaWrap Tendon Protector2020-10-22 VersaWrap Tendon Protector (K200311) is indicated for the management and protection of tendon injuries in which there has been n
B454VTP22010 - VersaWrap Tendon Protector2018-07-06 VersaWrap Tendon Protector (K160364) is indicated for the management and protection of tendon injuries in which there has been n

Trademark Results [VersaWrap]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERSAWRAP
VERSAWRAP
97066007 not registered Live/Pending
Techflex Inc.
2021-10-08
VERSAWRAP
VERSAWRAP
86553246 not registered Live/Pending
Alafair Biosciences, Inc.
2015-03-04
VERSAWRAP
VERSAWRAP
85169347 4119315 Live/Registered
CPG INTERNATIONAL LLC
2010-11-04
VERSAWRAP
VERSAWRAP
78063926 not registered Dead/Abandoned
Soltech, Inc.
2001-05-16
VERSAWRAP
VERSAWRAP
73640672 1465468 Dead/Cancelled
MINNESOTA DIVERSIFIED PRODUCTS, INC.
1987-01-20

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