Duns Number:004321519
Device Description: FISHERBRAND CONTAINR PHLEB 1QT
Catalog Number
22037970
Brand Name
Fisherbrand
Version/Model Number
31325410
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
37bc6572-a328-4a7e-97f8-560577588e58
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20613647000438
Quantity per Package
18
Contains DI Package
00613647000434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 129 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |