CPT®

Basic Information

• Brand Name: CPT®
• Primary DI: 00889024145757
• Version / Model: 8114-01
• Catalog Number: 00-8114-001-00
• Company Name: Zimmer, Inc.
• Labeler DUNS: 056038268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2020-04-09
• Public Version Status: Update
• Public Device Record Key: fd21c7b3-9476-4f53-88bd-2663be917d26

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
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34223	Uncoated hip femur prosthesis, one-piece	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is one-piece and is not coated with materials intended to improve fixation and stability. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) 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	00889024145757	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191735	000
K960658	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			12/14 Neck Taper, Size 1, 130, mm Stem Length