coflex Mallet cap

GUDID 04260148890147

Paradigm Spine, LLC

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Primary Device ID04260148890147
NIH Device Record Keyb4436d7b-e40a-4261-adc8-54a7465e82fb
Commercial Distribution StatusIn Commercial Distribution
Brand Namecoflex Mallet cap
Version Model NumberUAT20110
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
GS104260148890147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQOProsthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

Moist Heat or Steam Sterilization


[04260148890147]

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 Mallet cap]

04260148897863UAT20130
04260148890147UAT20110

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