Axis

GUDID 00841747184635

Axis Humeral Plate Assembly

COLLEGE PARK INDUSTRIES, INC.

Passive shoulder prosthesis

• Primary Device ID: 00841747184635
• NIH Device Record Key: c6467432-2ad0-4ff8-94e3-1caa77e147d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axis
• Version Model Number: SJ92
• Company DUNS: 623191137
• Company Name: COLLEGE PARK INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com
• Phone: 1-800-728-7950
• Email: orders@college-park.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841747184635 [Primary]

FDA Product Code

• IQQ: Joint, Shoulder, External Limb Component

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-06
• Device Publish Date: 2023-06-28

On-Brand Devices [Axis]

• 00841747184635: Axis Humeral Plate Assembly
• 00841747184611: Shoulder, Mounting Kit
• 00841747184598: Axis Locking Shoulder Joint, Exoskeletal, Electronic Lock Actuator, Black
• 00841747184581: Axis Locking Shoulder Joint, Endoskeletal, Electronic Lock Actuator, Black
• 00841747175572: Boston Arm Endo Adapter Kit
• 00841747175565: Nudge Kit, Black
• 00841747175558: Lock Release Kit, Black
• 00841747175541: Straight Mounting Plate, Aluminum
• 00841747175534: 3 Spoke Mounting Plate, Black
• 00841747175527: Axis Locking Shoulder Joint, Endoskeletal, Manual Lock Actuator, Black
• 00841747175510: Axis Locking Shoulder Joint, Exoskeletal, Manual Lock Actuator, Black
• 00195411451074: Spring Retainer
• 00195411451067: Cable Guide Clamp
• 00195411451050: Cable Guide Clamp Screw Kit (2 pc)
• 00195411451043: Swing Limiter Screw
• 00195411108589: Bowden Cable Housing Assembly Kit, X-Long
• 00195411036950: Cable Clamp Fastener Kit
• 00195411036943: Axis Shoulder Joint, Manual Lock Knob Kit
• 00195411036936: Axis Shoulder Joint, Mounting Plate Fastener Kit
• 00195411036929: Axis Shoulder Joint, Humeral Plate Fastener Kit