PureKit Gun MV

GUDID 03760177045361

TEKNIMED

Orthopaedic cement preparation/delivery kit
Primary Device ID03760177045361
NIH Device Record Key70775e5a-582d-4ba5-a8cb-c4e4094c577a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureKit Gun MV
Version Model NumberT060425MV
Company DUNS764746723
Company NameTEKNIMED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760177045361 [Primary]

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-04-01
Device Publish Date2023-03-30

On-Brand Devices [PureKit Gun MV]

03701505800498T060426MV
03760177045361T060425MV

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