LATITUDE EV™

Basic Information

• Brand Name: LATITUDE EV™
• Primary DI: 00846832072545
• Version / Model: 9039001
• Catalog Number: 9039001
• Company Name: TORNIER, INC.
• Labeler DUNS: 968990812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-08
• Public Version: 2
• Public Version Date: 2022-03-25
• Public Version Status: Update
• Public Device Record Key: 871e28cd-e6e9-4dc3-8f17-fa44a7d08d10

Device Characteristics

• Single Use: No
• 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: 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: 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
61212	Elbow radius prosthesis trial	A copy of a final elbow radius prosthesis designed to be used for trial reductions during elbow arthroplasty to help determine the correct size, length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846832072545	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	25	Millimeter
Outer Diameter	6	Millimeter