Max V Cement Mixing System 10001157

GUDID 03760177047426

TEKNIMED

Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit Orthopaedic cement preparation/delivery kit
Primary Device ID03760177047426
NIH Device Record Key01d06871-0f64-4e33-bc76-47808711ff59
Commercial Distribution StatusIn Commercial Distribution
Brand NameMax V Cement Mixing System
Version Model NumberNuVasive Cement Mixing System
Catalog Number10001157
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
GS103760177047426 [Primary]

FDA Product Code

JDZMixer, Cement, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-01
Device Publish Date2020-11-23

Devices Manufactured by TEKNIMED

03701505800016 - EUROSCREW NG Screwdriver Shaft2024-01-30
03701505800139 - Ratchet Handle2024-01-30
03701505800863 - TAP NG2024-01-29
03701505800870 - TAP NG2024-01-29
03701505800887 - TAP NG2024-01-29
03701505800894 - TAP NG2024-01-29
03701505800900 - TAP NG2024-01-29
03701505800917 - TAP NG2024-01-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.