INHANCE SHOULDER SYSTEM

Basic Information

• Brand Name: INHANCE SHOULDER SYSTEM
• Primary DI: 10603295551782
• Version / Model: 7701-38-440
• Catalog Number: 770138440
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-21
• Public Version: 1
• Public Version Date: 2025-03-03
• Public Version Status: New
• Public Device Record Key: 9bff0b66-37ef-45e2-a9e0-f82b2b80fb60

Device Description

INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL KIT 38 - 44mm NA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
HWT	TEMPLATE	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52522	Humeral head prosthesis trial, single-use	A sterile copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, or types for revision surgery. It is typically made of metal and/or polyethylene (PE). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295551782	GS1

Customer Contacts

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