NeuraGen® Nerve Guide PNG320

GUDID 10381780026471

NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® nerve guide provides a protective environment for peripheral nerve repair after injury, and is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. When hydrated, NeuraGen® nerve guide is an easy to handle, soft, pliable, nonfriable, porous collagen tube.

Integra Lifesciences Corporation

Nerve guide, bioabsorbable, synthetic

• Primary Device ID: 10381780026471
• NIH Device Record Key: c9197d42-55af-4c7f-a683-d15a17390aec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuraGen® Nerve Guide
• Version Model Number: PNG320
• Catalog Number: PNG320
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780026471 [Primary]
HIBCC	M269PNG3201 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011168

FDA Product Code

• JXI: CUFF, NERVE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [NeuraGen® Nerve Guide]

• 10381780071860: NEURAGEN 7MM 2CMNERVE GUIDE The NeuraGen nerve guide is an absorbable implant for the repair of
• 10381780071853: NEURAGEN 6MM 2CM NERVE GUIDE The NeuraGen nerve guide is an absorbable implant for the repair of
• 10381780071846: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780071839: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780071822: NEURAGEN 1.5MM X 3CM GUIDE The NeuraGen nerve guide is an absorbable implant for the repair of p
• 10381780026532: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780026525: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780026518: NEURAGEN 5MM 3CM GUIDE The NeuraGen nerve guide is an absorbable implant for the repair of perip
• 10381780026501: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780026495: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780026488: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780026471: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti
• 10381780026464: NeuraGen® nerve guide is an absorbable implant for the repair of peripheral nerve discontinuiti