ENDOPRO-MDTK

GUDID 00848657076937

Monostereo 3D Video System Enhancement

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera 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.

00848657076791 - Standard Hystero Grasper, D/A, 3mm x 37cm2024-07-10 Standard Hystero Grasper, D/A, 3mm x 37cm
00848657076807 - Rat Tooth Grasper, D/A, Rotating, 3mm x 37cm2024-07-10 A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp
00848657076814 - Curved Metz Scissor, D/A, Rotating, 3mm x 37cm2024-07-10 A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp
00848657076821 - Large Biopsy Cup Forcep, D/A, 3mm x 37cm2024-07-10 A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastr
00848657076920 - ENDOPRO-CAM Master Series2024-06-19 Endoscopic Video System
00848657076937 - ENDOPRO-MDTK2024-06-19Monostereo 3D Video System Enhancement
00848657076937 - ENDOPRO-MDTK2024-06-19 Monostereo 3D Video System Enhancement
00848657023108 - AED Power Bank Battery, Rechargeable2023-10-20 AED Power Bank Battery, Rechargeable
00848657068796 - Retractor2023-10-20 A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision t

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.