TEMA Elbow

Basic Information

• Brand Name: TEMA Elbow
• Primary DI: 08033390140218
• Version / Model: 1504.14.071
• Catalog Number: 1504.14.071
• Company Name: LIMACORPORATE SPA
• Labeler DUNS: 432066322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-24
• Public Version: 2
• Public Version Date: 2024-01-08
• Public Version Status: Update
• Public Device Record Key: 266695f0-f1fc-4b3d-9a78-01f672e43fdf

Device Description

Humeral Stem H7 right

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	888.3150	2
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	888.3160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33702	Uncoated elbow humerus prosthesis	A sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033390140218	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			H7 right