FDA.reportPublic FDA data

Nerve Tape®

Primary DI
G517NT40160
Brand
Nerve Tape®
Company
Biocircuit Technologies, Inc.
Model
NT40-16
Catalog number
NT40-16
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
G517NT40160PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-905-2204info@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
G517NT15140Nerve Tape®NT15-14NT15-142024-02-29
G517NT20140Nerve Tape®NT20-14NT20-142024-02-29
G517NT30140Nerve Tape®NT30-14NT30-142024-02-29
G517NT50160Nerve Tape®NT50-16NT50-162024-02-29
G517NT60220Nerve Tape®NT60-22NT60-222024-02-29
G517NT70220Nerve Tape®NT70-22NT70-222024-02-29

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