CarboClear Cervical Systems PL940103

GUDID 07290117351277

Screwdriver for use with the CarboClear cervical systems

CARBOFIX ORTHOPEDICS LTD

Surgical screwdriver, reusable
Primary Device ID07290117351277
NIH Device Record Keye1688b20-afa0-4b0f-9999-dce4b0352a58
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Cervical Systems
Version Model NumberScrewdriver Rod - T15
Catalog NumberPL940103
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
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
GS107290117351277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

[07290117351277]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-26
Device Publish Date2023-09-18

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07290117358436 - CarboClear Pedicle Screw Systems2026-03-05 Tool for cleaning instruments
17290117358792 - CarboClear Hybrid Pedicle Screw System2026-02-16 CarboClear Hybrid MIS Dual Thread Pedicle Screw - Cannulated
17290117358808 - CarboClear Hybrid Pedicle Screw System2026-02-16 CarboClear Hybrid MIS Dual Thread Pedicle Screw - Cannulated
17290117358815 - CarboClear Hybrid Pedicle Screw System2026-02-16 CarboClear Hybrid MIS Dual Thread Pedicle Screw - Cannulated
17290117358822 - CarboClear Hybrid Pedicle Screw System2026-02-16 CarboClear Hybrid MIS Dual Thread Pedicle Screw - Cannulated
17290117358839 - CarboClear Hybrid Pedicle Screw System2026-02-16 CarboClear Hybrid MIS Dual Thread Pedicle Screw - Cannulated
17290117358846 - CarboClear Hybrid Pedicle Screw System2026-02-16 CarboClear Hybrid MIS Dual Thread Pedicle Screw - Cannulated
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