FDA.reportPublic FDA data

NeuraWrap®

Primary DI
10381780026440
Brand
NeuraWrap®
Company
Integra Lifesciences Corporation
Model
NW540
Catalog number
NW540
Device description
NeuraWrap® Nerve Protector 5mm I.D. X 4cm Length
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K041620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041620000NEURA WRAP NERVE PROTECTORIntegra Lifesciences Corp.2004-07-16JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780026440PrimaryGS10
M269NW5401SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178002644010381780026440

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, bioabsorbable, syntheticAn implantable tubular device 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 made of a synthetic substance or material that can 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
Device Size Text, specify0
Device Size Text, specify0
Length4Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Avoid excessive heat and humidity. Do not refrigerate.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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