PureKit Syringe 1.5cc MV

GUDID 03701505801020

TEKNIMED

Orthopaedic cement preparation/delivery kit
Primary Device ID03701505801020
NIH Device Record Key240755a7-f0a2-438c-9342-22f01af9041b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureKit Syringe 1.5cc MV
Version Model NumberT060428MV
Company DUNS764746723
Company NameTEKNIMED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS103701505801020 [Primary]

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by TEKNIMED

03701505801020 - PureKit Syringe 1.5cc MV2025-04-08
03701505801020 - PureKit Syringe 1.5cc MV2025-04-08
03701505801037 - META+ System 1.5cc MV2025-04-08
03701505801075 - PUREKIT Syringes2025-04-08
03701505801082 - Syringes 4cc2025-04-08
03701505801099 - Syringes 1.5cc2025-04-08
03760177045361 - PureKit Gun MV2025-04-01
03760177040113 - OPACITY +2024-09-05
03760177041110 - F202024-09-05

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