INHANCE

Basic Information

• Brand Name: INHANCE
• Primary DI: 10603295550112
• Version / Model: 6005-30-306
• Catalog Number: 600530306
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-04
• Public Version: 3
• Public Version Date: 2022-12-16
• Public Version Status: Update
• Public Device Record Key: 224f6043-c971-4bd0-b6ba-827b66747b0c

Device Description

INHANCE SHOULDER SYSTEM TRIAL AUGMENT CASE COMPLETE

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented	Orthopedic	888.3660	2
PKC	Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained	Orthopedic	888.3660	2
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED	Orthopedic	888.3690	2
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3650	2
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2
MBF	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED	Orthopedic	888.3670	2
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
FSM	TRAY, SURGICAL, INSTRUMENT	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295550112	GS1

Customer Contacts

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