Duns Number:017416582
Device Description: A flexible fiber optic cable that is designed to transport light from a light source to an A flexible fiber optic cable that is designed to transport light from a light source to an instrument or other equipment, e.g., an endoscope or headlight. The fiber optic bundle is protected within a sheath and is made of glass fibers. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fiber optic bundle. This is a reusable device.
Catalog Number
-
Brand Name
Fiber Optic Light Cable
Version/Model Number
4.25mm bundle diameter, 8' length, mono cable
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021931
Product Code
FFS
Product Code Name
Image, Illumination, Fiberoptic, For Endoscope
Public Device Record Key
16562c22-b1a8-486d-8dcf-368193cf161e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 26, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |