Nerbridge®

Primary DI
04965838907418
Brand
Nerbridge®
Company
TOYOBO CO., LTD.
Model
RN01525E
Catalog number
RN01525E
Device description
Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge® is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge® is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge® is an easy to handle, pliable, soft, non-friable, porous conduit. The resilience of Nerbridge® allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge® is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.
Published
2018-04-20
Public version status
Update
Distribution status
Not 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
K152967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152967000NERBRIDGEToyobo Co., Ltd.2016-06-22JXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04965838907418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04965838907418049658389074184965838907418

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81663483336yuta_kawakatsu@toyobo.jp
+1(800)510-3318SMCA_Orders@Baxter.com
+818025456900xo_member@toyobo.jp

Regulatory Flags#

DUNS number
690538160
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04965838907401Nerbridge®RN01025ERN01025E2022-05-12
04965838907463Nerbridge®RN04025ERN04025E2022-05-12
04965838907395Nerbridge®RN00525ERN00525E2018-07-27
04965838907425Nerbridge®RN02025ERN02025E2018-04-20
04965838907449Nerbridge®RN03025ERN03025E2018-07-27
04965838907456Nerbridge®RN03525ERN03525E2018-07-27

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