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.

00848657023122 - AED2026-02-02 AED Flexible Grasping Forcep, 3Fr x 100cm, D/A
00848657023139 - AED2026-02-02 AED Flexible Grasping Forcep, 3Fr x 28cm, D/A
00848657068956 - AED2026-02-02 AED Flexible Grasper Forceps, 5Fr x 40cm, D/A
00848657069236 - AED2026-02-02 AED Flexible Biopsy Grasper, 0.9mm x 45cm, D/A
00848657069243 - AED2026-02-02 AED Flexible Biopsy Punch, 5FR x 30cm, S/A
00848657069250 - AED2026-02-02 AED Flexible Biopsy Grasper, 5Fr x 30cm, D/A
00848657069618 - AED2026-02-02 AED Flexible Scissor Forcep, 5FR x 47cm, S/A
00848657074889 - AED2026-02-02 AED Flexible Scissor Forcep, 5Fr x 40cm, S/A

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