coflex Crimping pliers

GUDID 04260148890123

Paradigm Spine, LLC

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Primary Device ID04260148890123
NIH Device Record Keye5cd1887-ea83-4b64-8c86-3bcb774d0331
Commercial Distribution StatusIn Commercial Distribution
Brand Namecoflex Crimping pliers
Version Model NumberUAT10200
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260148890123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQOProsthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


[04260148890123]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-29

On-Brand Devices [coflex Crimping pliers]

04260148898990UAT10220
04260148890123UAT10200

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