VersaWrap

Primary DI
B454VTP22010
Brand
VersaWrap
Company
Alafair Biosciences, Inc.
Model
VTP-2201
Catalog number
VTP-2201
Device description
VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
Published
2016-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical
JXICuff, Nerve
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
JXICuff, NerveNeurology2
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160364000VersaWrap Tendon ProtectorAlafair Biosciences, Inc.2016-06-10OWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B454VTP22010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tendon spacerAn implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Inch
Length5Centimeter
Total Volume1Milliliter
Width2Inch
Width5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968882709
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B454VSC10VersaWrapVSC-1VSC-12024-06-10
B454VTP12010VersaWrapVTP-1201VTP-12012020-11-01
B454VTP22011VersaWrap Tendon ProtectorVTP2201VTP22012020-10-23
B454VTP12011VersaWrap Tendon ProtectorVTP1201VTP12012020-10-14

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