Syringes 1.5cc

GUDID 03701505801099

TEKNIMED

Orthopaedic cement preparation/delivery kit
Primary Device ID03701505801099
NIH Device Record Keyb50fc185-3864-40a5-98d1-a76039e83eb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyringes 1.5cc
Version Model NumberT060428
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 Kitfalse
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
GS103701505801099 [Primary]

FDA Product Code

OARInjector, Vertebroplasty (Does Not Contain Cement)

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.