NeuroMend

Primary DI
00813954020150
Brand
NeuroMend
Company
COLLAGEN MATRIX, INC.
Model
CNW4050
Device description
Collagen Nerve Wrap 4mm (inner diameter) x 5cm (length)
Published
2015-09-16
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

Product Codes#

Code, Name table
CodeName
JXICuff, Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXICuff, NerveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060952000COLLAGEN NERVE WRAPCollagen Matrix, Inc.2006-07-14JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813954020150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954020150008139540201508139540201500813954020150

GMDN Terms#

Term, Definition table
TermDefinition
Nerve guide, bioabsorbable, animal-derivedAn 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 collagen matrix material (e.g., porcine-derived) 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
Length5Centimeter
Lumen/Inner Diameter4Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176262442
Device count
1
Lot or batch
true
Expiration date on label
true

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00813954028651AmpliDermAMPLIDERM-THICK-30X40AMPLIDERM-THICK-30X402026-04-06
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00813954028675AmpliDermAMPLIDERM-THIN-20X30AMPLIDERM-THIN-20X302026-04-06
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