KeriFlex

Basic Information

• Brand Name: KeriFlex
• Primary DI: 07640181160679
• Version / Model: 210-P20003
• Company Name: Keri Medical SA
• Labeler DUNS: 480138827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-20
• Public Version: 1
• Public Version Date: 2022-10-28
• Public Version Status: New
• Public Device Record Key: 250c63aa-2aee-47ef-bf06-51af7f7fd4e2

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
33697	Proximal interphalangeal joint prosthesis, one-piece	A sterile implantable artificial substitute for the proximal interphalangeal (PIP) 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 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	07640181160679	GS1

Premarket Submissions

Submission Number	Supplement Number
K211385	000