INHANCE

Basic Information

• Brand Name: INHANCE
• Primary DI: 10603295538271
• Version / Model: 5200-00-028
• Catalog Number: 520000028
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-17
• Public Version: 2
• Public Version Date: 2022-04-06
• Public Version Status: Update
• Public Device Record Key: 4742ecd0-93bc-42b5-9462-b6d8ab2cdeaf

Device Description

INHANCE SHOULDER SYSTEM STEMLESS X-SMALL DIAMETER 28mm CEMENTLESS

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 Conditional
• 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
PKC	Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained	Orthopedic	888.3660	2
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58950	Humeral metaphyseal anchor	A sterile implantable device designed to provide fixation within the humeral metaphysis for the attachment of a dedicated humeral head prosthesis. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is in the form of a small framework to achieve a mechanical interlock with bone without the use of bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295538271	GS1

Customer Contacts

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