Duns Number:017246562
Device Description: STERILE 8' STR KELLY HEMOSTAT (SK1008)
Catalog Number
67660
Brand Name
Centurion
Version/Model Number
67660
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
d65b890d-c97e-46b6-af3a-70133efa5568
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
December 31, 2021
Package DI Number
10653160196013
Quantity per Package
20
Contains DI Package
00653160196016
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 | 6043 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
| U | Unclassified | 1 |