CALCANAIL®

GUDID 03661489693151

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489693151
• NIH Device Record Key: 59b543ce-31a0-498b-9df4-5e350ab9d004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALCANAIL®
• Version Model Number: 269315 - CALCANAIL FRACTURE DISPOSABLE INSTRUMENTS
• Company DUNS: 261839898
• Company Name: FOURNITURES HOSPITALIERES INDUSTRIE
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661489693151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150463

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2018-10-30

On-Brand Devices [CALCANAIL®]

• 03661489683336: 268333- CALCANAIL CANNULATED SCREW Ø5 LG80MM
• 03661489683329: 268332- CALCANAIL CANNULATED SCREW Ø5 LG75MM
• 03661489683312: 268331-CALCANAIL CANNULATED SCREW Ø5 LG70MM
• 03661489683305: 268330- CALCANAIL CANNULATED SCREW Ø5 LG65MM
• 03661489683299: 268329- CALCANAIL CANNULATED SCREW Ø5 LG60MM
• 03661489683282: 268328- CALCANAIL CANNULATED SCREW Ø5 LG55MM
• 03661489683275: 268327- CALCANAIL CANNULATED SCREW Ø5 LG50MM
• 03661489683268: 268326- CALCANAIL CANNULATED SCREW Ø5 LG45MM
• 03661489683251: 268325- CALCANAIL CANNULATED SCREW Ø5 LG40MMD SCRE
• 03661489683244: 268324- CALCANAIL CANNULATED SCREW Ø5 LG38MM
• 03661489683237: 268323- CALCANAIL CANNULATED SCREW Ø5 LG36MM
• 03661489683220: 268322- CALCANAIL CANNULATED SCREW Ø5 LG34MM
• 03661489683213: 268321- CALCANAIL CANNULATED SCREW Ø5 LG32MM
• 03661489683206: 268320- CALCANAIL CANNULATED SCREW Ø5 LG30MM
• 03661489683190: 268319- CALCANAIL CANNULATED SCREW Ø5 LG28MM
• 03661489683183: 268318- CALCANAIL CANNULATED SCREW Ø5 LG26MM
• 03661489683176: 268317- CALCANAIL CANNULATED SCREW Ø5 LG24MM
• 03661489683169: 268316-Calcanail nail Ø12 Lg85mm + Cap_Arthodesis
• 03661489683152: 268315-Calcanail nail Ø12 Lg75mm + Cap_Arthodesis
• 03661489683145: 268314-Calcanail nail Ø12 Lg65mm + Cap_Arthodesis
• 03661489683138: 268313-Calcanail nail Ø10 Lg55mm + Cap_Fracture
• 03661489683121: 268312- Calcanail nail Ø10 Lg50mm + Cap_Fracture
• 03661489683114: 268311-Calcanail nail Ø10 Lg45mm + Cap_Fracture
• 03661489693168: 269316 - CALCANAIL ARTHRODESIS DISPOSABLE INSTRUME
• 03661489693151: 269315 - CALCANAIL FRACTURE DISPOSABLE INSTRUMENTS