ENDOPRO-MDTK

GUDID 00848657076937

Monostereo 3D Video System Enhancement

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope video camera
Primary Device ID00848657076937
NIH Device Record Key91e1ab2f-c7ee-4920-8211-2f43db1b0b35
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOPRO-MDTK
Version Model NumberEP-MDTK
Company DUNS839138955
Company NameNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS100848657076937 [Primary]

FDA Product Code

FWFCamera, Television, Endoscopic, Without Audio

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-19
Device Publish Date2024-06-11

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

00848657076975 - AED2024-07-30 AED Titanium Pistol Handle Needle Holder, 38cm, Straight Jaw; Non-Magnetic Version
00848657076982 - AED2024-07-30 Non-Magnetic Johan Bowel Grasper 5mm x 36cm
00848657076999 - AED2024-07-30 Non-Magnetic Maryland Grasper 5mm x 36cm, Serrated
00848657077002 - AED2024-07-30 Non-Magnetic Metzenbaum 5mm x 36cm, Curved
00848657077019 - AED2024-07-30 Precise Lap Bulldog Clamp with diamond dust anti-skid coating, 60mm, Non-Magnetic Version
00848657077026 - AED2024-07-30 Precise Lap Bulldog Clamp Forcep, 12.5mm x 38cm, Non-Magnetic Version
00848657076968 - ENDOPRO-CAM Master Series2024-07-23 Endoscopic Video System
00848657076791 - Standard Hystero Grasper, D/A, 3mm x 37cm2024-07-10 Standard Hystero Grasper, D/A, 3mm x 37cm

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