H-Series Loop Electrodes

GUDID GYNX1320051

GYNEX CORPORATION

Electrocautery system electrode
Primary Device IDGYNX1320051
NIH Device Record Key5612a429-1c41-478d-b3e5-0c99d26c03a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameH-Series Loop Electrodes
Version Model Number13-2005
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
HIBCCGYNX1320050 [Unit of Use]
HIBCCGYNX1320051 [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 Date2016-10-04

On-Brand Devices [H-Series Loop Electrodes]

GYNX132007113-2007
GYNX132005113-2005
GYNX131505113-1505
GYNX131010113-1010

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