Nerbridge® RN04025E

GUDID 04965838907463

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 in a foil pouch, sterile, non-pyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.

TOYOBO CO., LTD.

Nerve guide, bioabsorbable, animal-derived

• Primary Device ID: 04965838907463
• NIH Device Record Key: ef861231-7f64-4edc-9ff5-2a6d3fcdea22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nerbridge®
• Version Model Number: RN04025E
• Catalog Number: RN04025E
• Company DUNS: 690538160
• Company Name: TOYOBO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
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• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +1(800)510-3318
• Email: SMCA_Orders@Baxter.com
• Phone: +818025456900
• Email: xo_member@toyobo.jp
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• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
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• Phone: +818025456900
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• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
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• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
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• Phone: +818025456900
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• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
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• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
• Phone: +818025456900
• Email: xo_member@toyobo.jp
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• Phone: +818025456900
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• Phone: +818025456900
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• Phone: +818025456900
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• Phone: +818025456900
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• Phone: +818025456900
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Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
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• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04965838907463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152967

FDA Product Code

• JXI: Cuff, Nerve

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Nerbridge®]

• 04965838907456: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. N
• 04965838907449: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. N
• 04965838907425: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. N
• 04965838907418: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. N
• 04965838907395: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. N
• 04965838907463: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. N
• 04965838907401: Nerbridge® is a product composed of polyglycolic acid and collagen derived from porcine skin. N