NEUFLEX

Basic Information

• Brand Name: NEUFLEX
• Primary DI: 10603295017950
• Version / Model: 1234-10-000
• Catalog Number: 123410000
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Labeler DUNS: 080506581
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 6
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: f6c0a2e6-69b5-40fc-8661-a48e2dc1eb87
• Distribution End Date: 2022-03-31

Device Description

NEUFLEX MCP FINGER IMPLANT 10 CEMENTLESS

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
KYJ	PROSTHESIS, FINGER, CONSTRAINED, POLYMER	Orthopedic	888.3230	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33786	Metacarpophalangeal joint prosthesis, one-piece	An implantable artificial substitute for the metacarpophalangeal (MCP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component (one-piece) made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295017950	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970544	000