Square Electrodes 10x8mm LE-06-108

GUDID M803LE06108

Square Electrodes 10x8mm SQ Box 20

MEDGYN PRODUCTS, INC.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device IDM803LE06108
NIH Device Record Keyed7ccca1-fc28-4cc1-9973-58cef1a0d15c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSquare Electrodes 10x8mm
Version Model NumberSquare Electrodes 10x8mm SQ Box 20
Catalog NumberLE-06-108
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
HIBCCM803LE06108 [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.

M8030030134 - Baby Tischler Biopsy Punch Titanium2025-11-24 Baby Tischler Biopsy Punch Titanium 10" (254mm) - Angled Up
M8030030139 - Tischler Biopsy Punch Titanium2025-11-24 Tischler Biopsy Punch Titanium 8 1/2" (216mm) - Angled Left
M803029801 - Tischler Biopsy Punch 2025-11-24 Tischler Biopsy Punch 10" (254mm) Up
M803029802 - Tischler Biopsy Punch 2025-11-24 Tischler Biopsy Punch 10" (254mm) Down
M803029803 - Tischler Biopsy Punch2025-11-24 Tischler Biopsy Punch 10" (254mm) Left
M803029804 - Tischler Biopsy Punch 2025-11-24 Tischler Biopsy Punch 10" (254mm) Right
M803029811 - Baby Tischler Biopsy Punch 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Up
M803029812 - Baby Tischler Biopsy Punch 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Down

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.