NervAlign Nerve Cuff NA-NC3040

GUDID 09369998231904

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.

RENERVE LIMITED

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• Primary Device ID: 09369998231904
• NIH Device Record Key: 7a7079e7-9d3e-4fda-9fe4-896406f11fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NervAlign Nerve Cuff
• Version Model Number: NA-NC3040
• Catalog Number: NA-NC3040
• Company DUNS: 744429508
• Company Name: RENERVE LIMITED
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com
• Phone: +16122938673
• Email: customerserviceUS@nervalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09369998231904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202234

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: 2022-04-18
• Device Publish Date: 2022-04-08

On-Brand Devices [NervAlign Nerve Cuff]

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• 09369998146796: An absorbable collagen membrane implant that provides non-constricting protection for peripheral
• 09369998075812: An absorbable collagen membrane implant that provides non-constricting protection for peripheral