NeuroMatrix

Primary DI
00813954020020
Brand
NeuroMatrix
Company
COLLAGEN MATRIX, INC.
Model
CNC3025
Device description
Collagen Nerve Cuff 3mm (inner diameter) x 2.5cm (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
K012814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012814000COLLAGEN NERVE CUFFCollagen Matrix, Inc.2001-09-21JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813954020020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954020020008139540200208139540200200813954020020

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
Length2.5Centimeter
Lumen/Inner Diameter3Millimeter

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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