Duns Number:135057938
Device Description: Seeker® Crossing Support Catheter 0.035" Guidewire compatible, 90cm
Catalog Number
SK9035M
Brand Name
Seeker®
Version/Model Number
SK9035M
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
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
c7e7fa6d-65db-4940-ac1b-c45e9b333990
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
May 31, 2016
Package DI Number
10801741067959
Quantity per Package
5
Contains DI Package
00801741067952
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |