CoFix Sterilization Tray

GUDID 04260148897931

Paradigm Spine, LLC

Sterilization/disinfection container
Primary Device ID04260148897931
NIH Device Record Keydae41347-00f9-4362-bb01-3d9428b59460
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoFix Sterilization Tray
Version Model NumberRAC10000
Company DUNS787874960
Company NameParadigm Spine, LLC
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260148897931 [Primary]

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


[04260148897931]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-12
Device Publish Date2020-03-04

Devices Manufactured by Paradigm Spine, LLC

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04260148898242 - CoFix Implant 10 mm2020-03-27
04260148898259 - CoFix Implant 12 mm2020-03-27
04260148898266 - CoFix Implant 14 mm2020-03-27
04260148898273 - CoFix Implant 16 mm2020-03-27
04260148897931 - CoFix Sterilization Tray2020-03-12
04260148897931 - CoFix Sterilization Tray2020-03-12
04260636670459 - coflex-F LIS screw inserter2020-03-12
04260148896927 - DSS HP Polyaxial pedicle screw set, Ø5 x 45mm 2019-09-26

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