Duns Number:006261481
Device Description: PLI 6209BTK5S SOLOTRAK W/SN 9FR
Catalog Number
-
Brand Name
SOLO-TRAK®-KR
Version/Model Number
6209BTK5S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2018
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,K965167
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
58da15a7-487a-4341-94e3-17ddef05e530
Public Version Date
June 07, 2019
Public Version Number
5
DI Record Publish Date
January 03, 2017
Package DI Number
10721902577281
Quantity per Package
5
Contains DI Package
00721902577284
Package Discontinue Date
May 02, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| 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 |