Duns Number:961027315
Device Description: Wright Stain Buffer pH 7.15, 4.4 g vial
Catalog Number
B4136-3A
Brand Name
CARDINAL HEALTH
Version/Model Number
B4136-3A
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PPM
Product Code Name
General purpose reagent
Public Device Record Key
1392f19d-410c-4d48-b4b7-46420cf8ff4f
Public Version Date
September 10, 2021
Public Version Number
1
DI Record Publish Date
September 02, 2021
Package DI Number
20885380011747
Quantity per Package
10
Contains DI Package
00885380011743
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |