Piccolo Composite Plate System and CarboClear Cervical Plate System PL921870

GUDID 07290110208530

Screwdriver Ratchet Handle (for use with the Piccolo Composite Distal Radius Plate and CarboClear Cervical Plate systems)

CARBOFIX ORTHOPEDICS LTD

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 07290110208530
• NIH Device Record Key: 34a1fda2-13b0-4b90-91b3-916b57044dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Piccolo Composite Plate System and CarboClear Cervical Plate System
• Version Model Number: Screwdriver Ratchet Handle
• Catalog Number: PL921870
• Company DUNS: 649185170
• Company Name: CARBOFIX ORTHOPEDICS LTD
• 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: false
• 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

Customer Support Contacts

• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com
• Phone: 1-800-408-0120
• Email: usa@carbo-fix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110208530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102597

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

[07290110208530]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-08-25

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