NeuroShield

GUDID 07640181710201

NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve injuries by providing a protective barrierduring tissue healing.

Monarch Bioimplants GmbH

Nerve guide, bioabsorbable, animal-derived

• Primary Device ID: 07640181710201
• NIH Device Record Key: 115afdb5-d519-4b54-a3be-d83b2e907c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroShield
• Version Model Number: NS4030
• Company DUNS: 480144102
• Company Name: Monarch Bioimplants GmbH
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.com
• Phone: +41414552121
• Email: mail@monarchbioimplants.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640181710010 [Primary]
GS1	07640181710201 [Package]; Contains: 07640181710010; Package: Shipping carton [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: 2022-04-28
• Device Publish Date: 2022-04-20

On-Brand Devices [NeuroShield]

• 07640181710201: NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve inj
• 07640181711208: NeuroShield® is a chitosan polysaccharide film indicated for the repair of peripheral nerve inj