PERFORM™ HUMERAL SYSTEM

Basic Information

• Brand Name: PERFORM™ HUMERAL SYSTEM
• Primary DI: 00846832078226
• Version / Model: DWS3396
• Catalog Number: DWS3396
• Company Name: TORNIER, INC.
• Labeler DUNS: 968990812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-10
• Public Version: 2
• Public Version Date: 2022-03-29
• Public Version Status: Update
• Public Device Record Key: 99a881b8-8a6f-41be-961d-e6292470d40a

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48092	Polyethylene reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846832078226	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	39	Millimeter
Device Size Text, specify			Size 1 / 2
Device Size Text, specify			Thickness +6 mm