Square Electrodes 10x10mm LE-06-101

GUDID M803LE06101

Square Electrodes 10x10mm SQ Box 20

MEDGYN PRODUCTS, INC.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device IDM803LE06101
NIH Device Record Key18dcd67b-f932-402c-b9db-f9393c0f0da7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSquare Electrodes 10x10mm
Version Model NumberSquare Electrodes 10x10mm SQ Box 20
Catalog NumberLE-06-101
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
HIBCCM803LE06101 [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

Devices Manufactured by MEDGYN PRODUCTS, INC.

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