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 Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID07290110208530
NIH Device Record Key34a1fda2-13b0-4b90-91b3-916b57044dc5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePiccolo Composite Plate System and CarboClear Cervical Plate System
Version Model NumberScrewdriver Ratchet Handle
Catalog NumberPL921870
Company DUNS649185170
Company NameCARBOFIX ORTHOPEDICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com
Phone1-800-408-0120
Emailusa@carbo-fix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110208530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-02
Device Publish Date2020-08-25

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