AVAflex

Basic Information

• Brand Name: AVAflex
• Primary DI: 07613327374612
• Version / Model: 1025011000
• Catalog Number: 1025011000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-04
• Public Version: 1
• Public Version Date: 2018-06-04
• Public Version Status: New
• Public Device Record Key: 38cad0c4-73d6-4d35-913e-6ee411d1546d

Device Description

AVAflex Curved Needle Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
OAR	Injector, vertebroplasty (does not contain cement)	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47737	Orthopaedic cement injection cannula	A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327374612	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	11.0	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 12 – 25 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 60 Percent (%) Relative Humidity