Duns Number:038000253
Device Description: 12F X 20CM SILICONE SINGLE12F X LUMEN CATHETER SETLUMEN CATHETER W/STYLET & W/DILATOR
Catalog Number
SSL1220ME.
Brand Name
N/AN/A
Version/Model Number
SSL1220ME.
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
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
f9da788b-7469-4bb3-88f3-1cc4f4d2c35e
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
July 10, 2019
Package DI Number
50884908049546
Quantity per Package
10
Contains DI Package
00884908049541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |