VersaCoat Flowable Hydrogel

Primary DI
B454VTP44G20
Brand
VersaCoat Flowable Hydrogel
Company
Alafair Biosciences, Inc.
Model
VTP-44G2
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251505000
K251655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251505000VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair Biosciences2025-07-22JXI
K251655000VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair Biosciences2025-07-18OWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B454VTP44G20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, synthetic polymer, bioabsorbableAn implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

Storage And Handling#

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

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
B454VTP12G10VersaCoat Flowable HydrogelVTP-12G12025-12-21
B454VSC10VersaWrapVSC-1VSC-12024-06-10
B454VTP12010VersaWrapVTP-1201VTP-12012020-11-01
B454VTP22010VersaWrapVTP-2201VTP-22012016-12-15
B454VTP22011VersaWrap Tendon ProtectorVTP2201VTP22012020-10-23
B454VTP12011VersaWrap Tendon ProtectorVTP1201VTP12012020-10-14

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Primary DI, Brand, Company table
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