PERFORM™ HUMERAL SYSTEM

Basic Information

• Brand Name: PERFORM™ HUMERAL SYSTEM
• Primary DI: 00846832079186
• Version / Model: DWX934
• 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: 1
• Public Version Date: 2020-11-18
• Public Version Status: New
• Public Device Record Key: 6fa7f2b4-95d3-41c2-9fc8-1ad7ec602400

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
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60933	Humeral body extension prosthesis	A sterile implantable component of a reverse shoulder prosthesis that consists of a metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] piece intended to function as a spacer between a reverse shoulder body prosthesis and a reverse shoulder cup prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846832079186	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 3 / 4
Device Size Text, specify			Thickness 9 mm