DuaFit®

GUDID 03701337603014

Interphalangeal implants

IN2BONES

Proximal interphalangeal joint prosthesis, one-piece

• Primary Device ID: 03701337603014
• NIH Device Record Key: aee11a7e-ef83-494f-82cf-2ba0f57c1ef8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuaFit®
• Version Model Number: A60 SP002 B
• Company DUNS: 263616749
• Company Name: IN2BONES
• 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

Customer Support Contacts

• Phone: +33472292626
• Email: contact@in2bones.com

Device Dimensions

• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701337603014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132912

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [DuaFit®]

• 03701337603137: Interphalangeal implants
• 03701337603120: Interphalangeal implants
• 03701337603113: Interphalangeal implants
• 03701337603106: Interphalangeal implants
• 03701337603090: Interphalangeal implants
• 03701337603083: Interphalangeal implants
• 03701337603076: Interphalangeal implants
• 03701337603069: Interphalangeal implants
• 03701337603038: Interphalangeal implants
• 03701337603021: Interphalangeal implants
• 03701337603014: Interphalangeal implants
• 03701337603007: Interphalangeal implants
• 03760225715796: A06 00051
• 03760225715840: A06 00101
• 03760225715833: A06 00091
• 03760225715819: A06 00071
• 03760225715802: A06 00061
• 03760225712122: G01 00921
• 03760225710913: A06 10011
• 03760225710906: A06 10021
• 03760225718704: G01 10221