Duns Number:004382282
Device Description: FIBER-OPTIC LIGHT CABLE; STORZ/ACMI, RIGHT ANGLED, 5MM X 9'
Catalog Number
B79718
Brand Name
Fiberoptic Cable
Version/Model Number
B79718
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
FST
Product Code Name
Light, Surgical, Fiberoptic
Public Device Record Key
3ed08ed0-9b9b-44cf-a7ca-55a1ed52ad9a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 29, 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 | 5533 |
2 | A medical device with a moderate to high risk that requires special controls. | 240 |