Axis

Basic Information

• Brand Name: Axis
• Primary DI: 00841747184598
• Version / Model: SJ92 BK
• Company Name: COLLEGE PARK INDUSTRIES, INC.
• Labeler DUNS: 623191137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-28
• Public Version: 1
• Public Version Date: 2023-07-06
• Public Version Status: New
• Public Device Record Key: 5f5d250c-3c23-4c45-95a7-ebb1deea627f

Device Description

Axis Locking Shoulder Joint, Exoskeletal, Electronic Lock Actuator, Black

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41102	Passive shoulder prosthesis	An artificial substitute for a missing shoulder used as part of an upper-limb external prosthetic system and designed to be positioned by the application of external force.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841747184598	GS1

Customer Contacts

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