ENDOPRO-MDTK

GUDID 00848657076937

Monostereo 3D Video System Enhancement

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope video camera

• Primary Device ID: 00848657076937
• NIH Device Record Key: 91e1ab2f-c7ee-4920-8211-2f43db1b0b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPRO-MDTK
• Version Model Number: EP-MDTK
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657076937 [Primary]

FDA Product Code

• FWF: Camera, Television, Endoscopic, Without Audio

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-19
• Device Publish Date: 2024-06-11

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

• 00848657077729 - AED ENDOPRO® PRIMO SERIES CAMERA: 2025-10-03 AED ENDOPRO® PRIMO SERIES CAMERA
• 00848657077163 - AED: 2025-09-02 AED Laparoscope, 5mm X 43cm, 45 Degree
• 00848657077170 - AED: 2025-09-02 AED Laparoscope, 10mm X 50cm, 30 Degree
• 00848657077187 - AED: 2025-09-02 AED Laparoscope, 10mm X 43cm, 0 Degree
• 00848657077194 - AED: 2025-09-02 AED SINUS SIDE PUNCH LEFT #501.28
• 00848657077200 - AED: 2025-09-02 AED Endoscope - 5mm x 0 degree, 30cm
• 00848657077217 - AED: 2025-09-02 AED Laparoscope, 5mm X 30cm, 30 Degree
• 00848657077224 - AED: 2025-09-02 OLYMPUS MOUNT ARTHROSCOPE 4MM X 30 DEGREES, 160MM