AED ENDOPRO-CAM® EP2000

GUDID 00848657068192

AED ENDOPRO-CAM® ELITE Portable HD Endoscopic Video System: An electro-optical device (e.g., with an image sensor chip) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. This device includes a camera stand and rechargeable battery.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope video camera

• Primary Device ID: 00848657068192
• NIH Device Record Key: 40a8a1d4-a9a8-43f7-b7be-815965c17b0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED ENDOPRO-CAM®
• Version Model Number: EP2000
• Catalog Number: EP2000
• 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: false
• 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

Customer Support Contacts

• Phone: 8182272720
• Email: customerservice@aed.md

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657068192 [Primary]

FDA Product Code

• FWD: Camera, Television, Microsurgical, 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: 2020-03-12
• Device Publish Date: 2020-03-04

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

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• 00848657076999 - AED: 2024-07-30 Non-Magnetic Maryland Grasper 5mm x 36cm, Serrated
• 00848657077002 - AED: 2024-07-30 Non-Magnetic Metzenbaum 5mm x 36cm, Curved
• 00848657077019 - AED: 2024-07-30 Precise Lap Bulldog Clamp with diamond dust anti-skid coating, 60mm, Non-Magnetic Version
• 00848657077026 - AED: 2024-07-30 Precise Lap Bulldog Clamp Forcep, 12.5mm x 38cm, Non-Magnetic Version
• 00848657076968 - ENDOPRO-CAM Master Series: 2024-07-23 Endoscopic Video System
• 00848657076791 - Standard Hystero Grasper, D/A, 3mm x 37cm: 2024-07-10 Standard Hystero Grasper, D/A, 3mm x 37cm