Duns Number:055870299
Device Description: Fiber Optic Light Cable 1 Lgt input & 2 outputs, 4.8 x 2300mm, 7.5 ft. Lg without adapters
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.FOC178/75
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EQH
Product Code Name
Source, Carrier, Fiberoptic Light
Public Device Record Key
aeb96f8c-bc86-4d8d-9e45-5c6a8190693c
Public Version Date
July 08, 2020
Public Version Number
1
DI Record Publish Date
June 30, 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 | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |