Duns Number:006261481
Device Description: INTRO 6210BTKL1 KINK RESIST X-LONG 10L
Catalog Number
-
Brand Name
SOLO-TRAK®-KR
Version/Model Number
6210BTKL1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 10, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K965167
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
36e83b0a-1077-4d50-9360-d748ed454065
Public Version Date
September 22, 2022
Public Version Number
5
DI Record Publish Date
January 03, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |