NA

Basic Information

• Brand Name: NA
• Primary DI: 00889024639775
• Version / Model: 32-8105-29
• Catalog Number: 32-8105-029-00
• Company Name: Zimmer, Inc.
• Labeler DUNS: 056038268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-25
• Public Version: 1
• Public Version Date: 2022-03-07
• Public Version Status: New
• Public Device Record Key: 1a9abfaf-c9b0-457b-baf2-c454ecfffd69

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: MR Conditional
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
40124	Hinged total elbow prosthesis	A sterile implantable artificial substitute for an elbow joint designed to replace the articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes humeral and ulnar components, typically with parts made of metal and polyethylene (PE), that form a hinge at articulation. The device may include fixation devices (e.g., screws) for implantation and may be implanted with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024639775	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001989	000
K181307	000