Checkpoint NeuroShield Chitosan Membrane NS4030

GUDID B130NS40300

NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.

Checkpoint Surgical, Inc.

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• Primary Device ID: B130NS40300
• NIH Device Record Key: fae01e56-04f3-4f3d-910e-e0b79a029093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Checkpoint NeuroShield Chitosan Membrane
• Version Model Number: NS4030
• Catalog Number: NS4030
• Company DUNS: 832575364
• Company Name: Checkpoint Surgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B130NS40300 [Primary]
HIBCC	B130NS40301 [Package]; Package: pouch [1 Units]; In Commercial Distribution
HIBCC	B130NS40302 [Package]; Contains: B130NS40301; Package: Sales Carton [1 Units]; In Commercial Distribution
HIBCC	B130NS40303 [Package]; Contains: B130NS40302; Package: Shipping Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190246

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: 2023-04-10
• Device Publish Date: 2023-03-31

On-Brand Devices [Checkpoint NeuroShield Chitosan Membrane]

• B130NS40300: NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral ne
• B130NS30201: NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral ne