Mediflex Laparoscopic Instruments - Reusable Electrodes 91175-45

GUDID 00842102104992

L-Hook Electrode, 5mm x 45cm

FLEXBAR MACHINE CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device ID00842102104992
NIH Device Record Key1cb47c4f-4f3c-4612-85d4-2537913fc879
Commercial Distribution StatusIn Commercial Distribution
Brand NameMediflex Laparoscopic Instruments - Reusable Electrodes
Version Model Number91175-45
Catalog Number91175-45
Company DUNS047644935
Company NameFLEXBAR MACHINE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842102104992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842102104992]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-17

On-Brand Devices [Mediflex Laparoscopic Instruments - Reusable Electrodes]

00842102105005J-Hook Electrode, 5mm x 45cm
00842102104992L-Hook Electrode, 5mm x 45cm
00842102104985Spatula Tip Electrode, 5mm x 45cm
00842102104978J-Hook Electrode, 5mm x 33cm
00842102104961L-Hook Electrode, 5mm x 33cm
00842102104954Spatula Tip Electrode, 5mm x 33cm
00842102104947Spatula Cautery 3.5mm x 33cm
00842102104930J Hook Cautery 3.5mm x 33cm
00842102104923L Hook Cautery 3.5mm x 33cm
00842102104916Spatula Cautery, 3.5mm x 26cm
00842102104909J Hook Cautery, 3.5mm x 26cm
00842102104893L Hook Cautery, 3.5mm x 26cm

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