CarboClear Pedicle Screw Systems PPLCR6045

GUDID 17290109335985

Straight Rod of the CarboClear X Pedicle Screw System (MIS)

CARBOFIX ORTHOPEDICS LTD

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Primary Device ID17290109335985
NIH Device Record Keye84af963-82bd-4846-b862-338cdb661e9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Pedicle Screw Systems
Version Model NumberCurved Rod
Catalog NumberPPLCR6045
Company DUNS649185170
Company NameCARBOFIX ORTHOPEDICS LTD
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
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 Dimensions

Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter
Outer Diameter6 Millimeter
Length45 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109335988 [Primary]
GS117290109335985 [Package]
Contains: 07290109335988
Package: [2 Units]
In Commercial Distribution
GS127290109335982 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-27
Device Publish Date2023-09-19

On-Brand Devices [CarboClear Pedicle Screw Systems]

17290117351243Curved Rod of the CarboClear Pedicle Screw Systems (MIS)
17290109336050Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109336043Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109336036Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109336029Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109336012Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109336005Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335992Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335985Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335978Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335947Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335930Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335923Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335916Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335909Straight Rod of the CarboClear X Pedicle Screw System (MIS)
27290109335890Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335886Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335879Straight Rod of the CarboClear X Pedicle Screw System (MIS)
17290109335862Straight Rod of the CarboClear X Pedicle Screw System (MIS)
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