Loop Electrodes 15x8mm LE-07-158

GUDID M803LE07158

Loop Electrodes 15x8mm Box 20

MEDGYN PRODUCTS, INC.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device IDM803LE07158
NIH Device Record Keyb429ab0f-d1f2-4e47-ba6b-f1b47bf27556
Commercial Distribution StatusIn Commercial Distribution
Brand NameLoop Electrodes 15x8mm
Version Model NumberLoop Electrodes 15x8mm Box 20
Catalog NumberLE-07-158
Company DUNS103913430
Company NameMEDGYN PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
HIBCCM803LE07158 [Primary]

FDA Product Code

HGIElectrocautery, Gynecologic (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-11
Device Publish Date2024-01-03

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