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.
Catalog Number
CPL 35
Brand Name
AED 35MM Optical Coupler
Version/Model Number
CPL 35
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
FEM
Product Code Name
Accessories, Photographic, For Endoscope (Exclude Light Sources)
Public Device Record Key
74122018-8eed-4138-8a98-4cbca432295b
Public Version Date
March 19, 2021
Public Version Number
2
DI Record Publish Date
March 06, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |