AED 22MM Optical Coupler - Optical Coupler: The device is designed to - NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Duns Number:839138955

Device Description: Optical Coupler: The device is designed to connect a camera (moving- or still-image) to a Optical Coupler: The device is designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.

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More Product Details

Catalog Number

CPL 22

Brand Name

AED 22MM Optical Coupler

Version/Model Number

CPL 22

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FEM

Product Code Name

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Device Record Status

Public Device Record Key

c7fea6ba-3bc8-48c4-85ab-1f24df1b9d3e

Public Version Date

March 19, 2021

Public Version Number

2

DI Record Publish Date

March 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATIONAL ADVANCED ENDOSCOPY DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 579
2 A medical device with a moderate to high risk that requires special controls. 6418