Carrera Loop Electrode

GUDID GYNXOCMR15081

GYNEX CORPORATION

Electrocautery system electrode
Primary Device IDGYNXOCMR15081
NIH Device Record Key7569c748-1ddd-4d24-8eab-421ba202caa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarrera Loop Electrode
Version Model NumberOCMR-1508
Company DUNS012997685
Company NameGYNEX CORPORATION
Device Count5
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
HIBCCGYNXOCMR15080 [Unit of Use]
HIBCCGYNXOCMR15081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGIElectrocautery, Gynecologic (And 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 Date2017-01-19

On-Brand Devices [Carrera Loop Electrode]

GYNXOCMR15081OCMR-1508
GYNXCMB2321CMB-2-3-2

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