KeriFlex

GUDID 07640181160679

Keri Medical SA

Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece Proximal interphalangeal joint prosthesis, one-piece

• Primary Device ID: 07640181160679
• NIH Device Record Key: 250c63aa-2aee-47ef-bf06-51af7f7fd4e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KeriFlex
• Version Model Number: 210-P20003
• Company DUNS: 480138827
• Company Name: Keri Medical SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640181160679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211385

FDA Product Code

• KYJ: Prosthesis, Finger, Constrained, Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-28
• Device Publish Date: 2022-10-20

On-Brand Devices [KeriFlex]

• 07640181160693: 210-P20005
• 07640181160686: 210-P20004
• 07640181160679: 210-P20003
• 07640181160662: 210-P20002
• 07640181160655: 210-P20001
• 07640181160648: 210-P10060
• 07640181160631: 210-P10050
• 07640181160624: 210-P10040
• 07640181160617: 210-P10030
• 07640181160600: 210-P10020
• 07640181160594: 210-P10010
• 07640181160587: 210-P10000