Duns Number:961027315
Device Description: STRAIGHT KELLY HEMOSTAT
Catalog Number
33048-002A
Brand Name
CARDINAL HEALTH
Version/Model Number
33048-002A
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
Yes
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
HRQ
Product Code Name
HEMOSTAT
Public Device Record Key
8d24b4c8-6e0f-4cce-a981-372e3f6c924a
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
August 16, 2016
Package DI Number
50885425502002
Quantity per Package
50
Contains DI Package
10885425502004
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 | 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 |