NervAlign Nerve Cuff

Primary DI
09369998231904
Brand
NervAlign Nerve Cuff
Company
RENERVE LIMITED
Model
NA-NC3040
Catalog number
NA-NC3040
Device description
An absorbable collagen membrane implant that provides non-constricting protection for peripheral nerves. It is designed to be an interface between the nerve and the surrounding tissue and used for the repair of peripheral nerves in which there is no gap or where a gap closure is achieved by flexion of the extremity.
Published
2022-04-08
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
K202234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202234000NervAlign Nerve CuffRenerve, Ltd.2022-02-10JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09369998231904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09369998231904093699982319049369998231904

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 an animal-derived material (e.g., porcine-derived collagen matrix, chitosan) 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+16122938673customerserviceUS@nervalign.com

Regulatory Flags#

DUNS number
744429508
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09369998075812NervAlign Nerve CuffNA-NC1010NA-NC10102022-04-08
09369998146796NervAlign Nerve CuffNA-NC2030NA-NC20302022-04-08

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