Duns Number:484942081
Device Description: FISSO Fastening Straps black. Includes 2 straps, Art.: 93.285
Catalog Number
5.890
Brand Name
FISSO
Version/Model Number
5.890-VE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2022
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
db3c01ca-31ab-47a0-b216-da76b16a1ebb
Public Version Date
May 02, 2022
Public Version Number
3
DI Record Publish Date
October 30, 2021
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 | 33 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |