MEDINAUT Flex

GUDID 08800038044944

IMEDICOM CO., LTD.

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 ID08800038044944
NIH Device Record Key1c8c8514-00c8-4450-852e-32713a81dcd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDINAUT Flex
Version Model NumberMDF1
Company DUNS690340653
Company NameIMEDICOM CO., LTD.
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
GS108800038044944 [Primary]

FDA Product Code

OCJSpinal Channeling Instrument, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-26
Device Publish Date2020-10-16

Devices Manufactured by IMEDICOM CO., LTD.

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08800038058286 - SYNTH™ PLUS2024-04-02
08800038058293 - SYNTH™ PLUS2024-04-02
08800038058309 - SYNTH™ PLUS2024-04-02
08800038058316 - SYNTH™ PLUS BILATERAL2024-04-02
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