NeuraGen®

Primary DI
10381780071846
Brand
NeuraGen®
Company
Integra Lifesciences Corporation
Model
PNG420
Catalog number
PNG-420
Device description
NeuraGen® Nerve Guide 4mm (ID) X 2cm (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
K011168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011168000NEUROGEN NERVE GUIDEIntegra Lifesciences Corp.2001-06-22JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780071846PrimaryGS10
M269PNG4201SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007184610381780071846

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Avoid excessive heat or 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780112075Integra OS™IOS10125IOS101252015-09-23
10381780112082Integra OS™IOS10155IOS101552015-09-23
10381780112426Trel-XC PasteTXCPA01TXCPA012015-09-22
10381780112433Trel-XC PasteTXCPA03TXCPA032015-09-22
10381780112440Trel-XC PasteTXCPA08TXCPA082015-09-22
10381780112457Trel-XC PuttyTXCPY05TXCPY052015-09-22
10381780112464Trel-XC PuttyTXCPY10TXCPY102015-09-22
10381780112471Trel-X PuttyTXP05TXP052015-09-22
10381780112488Trel-X PuttyTXP10TXP102015-09-22
10381780112495Trel-X GelTXG01TXG012015-09-22
10381780112501Trel-X GelTXG05TXG052015-09-22
10381780112518Trel X-Press 100XPRES110XPRES1102015-09-22
10381780112525Trel X-Press 100XPRES105XPRES1052015-09-22
10381780112532Trel X-Press 100XPRES125XPRES1252015-09-22
10381780112556Trel X-Press 300XPRES305XPRES3052015-09-25
10381780112563Trel X-Press 300XPRES325XPRES3252015-09-25
10381780112570Trel XPress 300CXPres3c10XPres3c102015-09-25
10381780114338Collage Osteoconductive Scaffold - Putty7100057100052015-09-22
10381780114345Collage Osteoconductive Scaffold - Putty7100107100102015-09-22
10381780114352Collage Osteoconductive Scaffold - Putty7100157100152015-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179630065AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630089AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630102AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630126AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630140AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630164AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630188AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630201AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630225AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630263AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630287AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630300AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630324AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630348AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630362AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630386AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630409AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630423AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630447AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630461AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630478AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00810179630492AxoGuardCOOK BIOTECH INCORPORATEDJXI2026-07-31
00813954029214CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029221CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029238CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029245CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-31
00813954029252CHECKPOINT AxioCorCOLLAGEN MATRIX, INC.JXI2026-07-30
B454VTP12G10VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-12-21
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.JXI2025-11-21
G517CW2040ConformaWrapBiocircuit Technologies, Inc.JXI2025-09-10