Sterile Disposable Instruments

GUDID 00817906024210

Sterile Disposable Instruments for Ø2.4 and Ø 2.7 mm Plate Screws

IN2BONES USA, LLC

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00817906024210
• NIH Device Record Key: 356e4c2d-f5c1-4736-8048-7370df33b961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Instruments
• Version Model Number: P06 S0001
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906024210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170518

FDA Product Code

• LXH: Orthopedic manual surgical instrument

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: 2018-03-29
• Device Publish Date: 2017-07-28

On-Brand Devices [Sterile Disposable Instruments]

• 00817906024210: Sterile Disposable Instruments for Ø2.4 and Ø 2.7 mm Plate Screws
• 00817906024203: Sterile Disposable Instruments for Ø3.0 and Ø 3.5 mm Plate Screws