AxoGuard

Basic Information

• Brand Name: AxoGuard
• Primary DI: 00827002528048
• Version / Model: G52804
• Catalog Number: AG0540
• Company Name: COOK BIOTECH INCORPORATED
• Labeler DUNS: 945385862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-03
• Public Version: 7
• Public Version Date: 2022-03-25
• Public Version Status: Update
• Public Device Record Key: e89c4f61-66d7-4500-be86-357b75e3fb79

Device Description

AxoGuard Nerve Protector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXI	CUFF, NERVE	Neurology	882.5275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43233	Nerve guide, bioabsorbable, animal-derived	An implantable tubular device intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is made of an animal-derived material (e.g., porcine-derived collagen matrix, chitosan) that can be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002528048	GS1
Package	10827002528045	GS1		1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132660	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean, dry location at room temperature
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius