coflex Mallet

GUDID 04260148897856

Paradigm Spine, LLC

General internal orthopaedic fixation system implantation kit
Primary Device ID04260148897856
NIH Device Record Key3cd56480-1886-45d9-9137-698572de06df
Commercial Distribution StatusIn Commercial Distribution
Brand Namecoflex Mallet
Version Model NumberUAT20120
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
GS104260148897856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQOProsthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-03
Device Publish Date2018-08-02

On-Brand Devices [coflex Mallet]

04260148897856UAT20120
04260148890130UAT20100

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