SubChon C01 S1001

GUDID 00810021866765

SubChon Sizing Kit, Single-Use, Sterile

IN2BONES USA, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00810021866765
• NIH Device Record Key: c185344a-52a3-4445-bae3-d7a8f5664fca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SubChon
• Version Model Number: C01 S1001
• Catalog Number: C01 S1001
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021866765 [Primary]

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: 2024-12-31
• Device Publish Date: 2024-12-10

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• 00810021866802: SubChon Instrument Kit, Size 9mm, Single-Use, Sterile
• 00810021866796: SubChon Instrument Kit, Size 7mm, Single-Use, Sterile
• 00810021866789: SubChon Instrument Kit, Size 5mm, Single-Use, Sterile
• 00810021866765: SubChon Sizing Kit, Single-Use, Sterile
• 00810021866758: SubChon Instrument Kit, Size 11mm, Single-Use, Sterile
• 00810021866741: SubChon Instrument Kit, Size 9mm, Single-Use, Sterile
• 00810021866734: SubChon Instrument Kit, Size 7mm, Single-Use, Sterile
• 00810021866727: SubChon Instrument Kit, Size 5mm, Single-Use, Sterile