Duns Number:092364462
Catalog Number
-
Brand Name
Medtronic
Version/Model Number
KPKS002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2017
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRO
Product Code Name
General surgery tray
Public Device Record Key
4d1c148f-fdde-4f78-84cb-4751f730faea
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
April 24, 2017
Package DI Number
20809160145620
Quantity per Package
10
Contains DI Package
10809160145623
Package Discontinue Date
September 25, 2017
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |