Electrode Handpiece, Hand Activated

GUDID GYNX755VL1

GYNEX CORPORATION

Electrocautery system handpiece
Primary Device IDGYNX755VL1
NIH Device Record Keyf6675970-a55d-4439-993a-e98260674aed
Commercial Distribution StatusIn Commercial Distribution
Brand NameElectrode Handpiece, Hand Activated
Version Model Number755VL
Company DUNS012997685
Company NameGYNEX CORPORATION
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCGYNX755VL0 [Unit of Use]
HIBCCGYNX755VL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-05

Devices Manufactured by GYNEX CORPORATION

GYNX16000 - Gynex2024-01-03
GYNX291000 - Gynex2024-01-03
GYNX292000 - Gynex2024-01-03
GYNX293500 - Gynex2024-01-03
GYNX295500 - Gynex2024-01-03
GYNX297000 - Gynex2024-01-03
GYNX298000 - Gynex2024-01-03
GYNX298500 - Gynex2024-01-03

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