AxoGuard AG0320

GUDID 10827002527901

AxoGuard Nerve Protector

COOK BIOTECH INCORPORATED

Nerve guide, bioabsorbable, animal-derived

• Primary Device ID: 10827002527901
• NIH Device Record Key: ceca314e-9e8d-42e8-936d-90d5861c8834
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxoGuard
• Version Model Number: G52790
• Catalog Number: AG0320
• Company DUNS: 945385862
• Company Name: COOK BIOTECH INCORPORATED
• 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: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in clean, dry location at room temperature
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002527901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132660

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: 5
• Public Version Date: 2021-12-08
• Device Publish Date: 2015-11-03

On-Brand Devices [AxoGuard]

• 10827002528045: AxoGuard Nerve Protector
• 10827002528038: AxoGuard Nerve Protector
• 10827002528021: AxoGuard Nerve Protector
• 10827002528014: AxoGuard Nerve Protector
• 10827002528007: AxoGuard Nerve Protector
• 10827002527994: AxoGuard Nerve Connector
• 10827002527987: AxoGuard Nerve Connector
• 10827002527970: AxoGuard Nerve Connector
• 10827002527963: AxoGuard Nerve Connector
• 10827002527956: AxoGuard Nerve Connector
• 10827002527949: AxoGuard Nerve Connector
• 10827002527932: AxoGuard Nerve Connector
• 10827002527925: AxoGuard Nerve Protector
• 10827002527918: AxoGuard Nerve Protector
• 10827002527901: AxoGuard Nerve Protector
• 10827002527895: AxoGuard Nerve Protector
• 10827002351353: AxoGuard Nerve Connector
• 10827002351346: AxoGuard Nerve Connector
• 10827002351339: AxoGuard Nerve Connector
• 10827002351322: AxoGuard Nerve Connector
• 10827002351315: AxoGuard Nerve Connector
• 10827002351308: AxoGuard Nerve Connector
• 10827002351285: AxoGuard Nerve Connector
• 00827002528048: AxoGuard Nerve Protector
• 00827002528031: AxoGuard Nerve Protector
• 00827002528024: AxoGuard Nerve Protector
• 00827002528017: AxoGuard Nerve Protector
• 00827002528000: AxoGuard Nerve Protector
• 00827002527997: AxoGuard Nerve Connector
• 00827002527980: AxoGuard Nerve Connector
• 00827002527973: AxoGuard Nerve Connector
• 00827002527966: AxoGuard Nerve Connector
• 00827002527959: AxoGuard Nerve Connector
• 00827002527942: AxoGuard Nerve Connector
• 00827002527935: AxoGuard Nerve Connector
• 00827002527928: AxoGuard Nerve Protector
• 00827002527911: AxoGuard Nerve Protector
• 00827002527904: AxoGuard Nerve Protector
• 00827002527898: AxoGuard Nerve Protector
• 00827002351356: AxoGuard Nerve Connector
• 00827002351349: AxoGuard Nerve Connector
• 00827002351332: AxoGuard Nerve Connector
• 00827002351325: AxoGuard Nerve Connector
• 00827002351318: AxoGuard Nerve Connector
• 00827002351301: AxoGuard Nerve Connector
• 00827002351288: AxoGuard Nerve Connector