FDA.reportPublic FDA data

Nerve Tape®

Primary DI
G517NT15140
Brand
Nerve Tape®
Company
Biocircuit Technologies, Inc.
Model
NT15-14
Catalog number
NT15-14
Device description
Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surroundingtissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coaptednerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold theends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.
Published
2024-02-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXICuff, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233533000NerveTapeBiocircuit Technologies, Inc.2024-02-12JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G517NT15140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, animal-derivedAn implantable tubular device made exclusively of animal-derived bioabsorbable material(s) [e.g., porcine-derived collagen matrix, chitosan] intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is intended to be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter1.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-905-2204support@biocircuit.com

Regulatory Flags#

DUNS number
116978015
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G517CW2040ConformaWrapCW2040CW20402025-09-10
G517CW4080ConformaWrapCW4080CW40802025-09-10
G517NT20140Nerve Tape®NT20-14NT20-142024-02-29
G517NT30140Nerve Tape®NT30-14NT30-142024-02-29
G517NT40160Nerve Tape®NT40-16NT40-162024-02-29
G517NT50160Nerve Tape®NT50-16NT50-162024-02-29
G517NT60220Nerve Tape®NT60-22NT60-222024-02-29
G517NT70220Nerve Tape®NT70-22NT70-222024-02-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B454VTP12G10VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-12-21
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-11-21
G517CW2040ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10
G517CW4080ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10
00813954027272Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027289Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027296Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027302Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027319Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027326Arthrex Nerve ConduitCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027333Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027340Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027357Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027364Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027371Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
00813954027388Arthrex Nerve WrapCOLLAGEN MATRIX, INC.JXI2025-07-25
06975222390007Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390014Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390021Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390038Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390045Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390052Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390069Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390076Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390083Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
06975222390090Rebuilder Nerve Guidance ConduitNingbo Guangyuan Zhixin Biological Technology Co., Ltd.JXI2025-05-20
09358206000043Remplir™ORTHOCELL LIMITEDJXI2025-04-07
09358206000074Remplir™ORTHOCELL LIMITEDJXI2025-04-07
19358206000040Remplir™ORTHOCELL LIMITEDJXI2025-04-07
09358206000050Remplir™ORTHOCELL LIMITEDJXI2025-04-07