Flow-Nail™ 101-06

GUDID B267101060

FN Guidewire (3.2mm)

Flow-FX

Femur nail, non-sterile

• Primary Device ID: B267101060
• NIH Device Record Key: ffb477d7-7d5c-4afb-91d8-8fe22fd0c35f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow-Nail™
• Version Model Number: 101-06
• Catalog Number: 101-06
• Company DUNS: 079293587
• Company Name: Flow-FX
• 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: false
• 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
HIBCC	B267101060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140601

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[B267101060]

Moist Heat or Steam Sterilization

[B267101060]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-23
• Device Publish Date: 2018-06-21

On-Brand Devices [Flow-Nail™ ]

• B267C801: FN 80mm CORT Screw
• B267C800: FN 80mm CORT Screw
• B267C751: FN 75mm CORT Screw
• B267C750: FN 75mm CORT Screw
• B267C701: FN 70mm CORT Screw
• B267C700: FN 70mm CORT Screw
• B267C651: FN 65mm CORT Screw
• B267C650: FN 65mm CORT Screw
• B267C601: FN 60mm CORT Screw
• B267C600: FN 60mm CORT Screw
• B267C581: FN 58mm CORT Screw
• B267C580: FN 58mm CORT Screw
• B267C561: FN 56mm CORT Screw
• B267C560: FN 56mm CORT Screw
• B267C541: FN 54mm CORT Screw
• B267C540: FN 54mm CORT Screw
• B267C521: FN 52mm CORT Screw
• B267C520: FN 52mm CORT Screw
• B267C501: FN 50mm CORT Screw
• B267C500: FN 50mm CORT Screw
• B267C481: FN 48mm CORT Screw
• B267C480: FN 48mm CORT Screw
• B267C461: FN 46mm CORT Screw
• B267C460: FN 46mm CORT Screw
• B267C441: FN 44mm CORT Screw
• B267C440: FN 44mm CORT Screw
• B267C421: FN 42mm CORT Screw
• B267C420: FN 42mm CORT Screw
• B267C401: FN 40mm CORT Screw
• B267C381: FN 38mm CORT Screw
• B267C380: FN 38mm CORT Screw
• B267C361: FN 36mm CORT Screw
• B267C360: FN 36mm CORT Screw
• B267C341: FN 34mm CORT Screw
• B267C340: FN 34mm CORT Screw
• B267C321: FN 32mm CORT Screw
• B267C320: FN 32mm CORT Screw
• B267C301: FN 30mm CORT Screw
• B267C300: FN 30mm CORT Screw
• B267C281: FN 28mm CORT Screw
• B267C280: FN 28mm CORT Screw
• B267C261: FN 26mm CORT Screw
• B267C260: FN 26mm CORT Screw
• B267C241: FN 24mm CORT Screw
• B267C240: FN 24mm CORT Screw
• B267C221: FN 22mm CORT Screw
• B267C220: FN 22mm CORT Screw
• B267C201: FN 20mm CORT Screw
• B267C200: FN 20mm CORT Screw
• B267A901: FN AR Screw 90mm