Duns Number:024954518
Device Description: 12 gram tip, long taper, .014" diameter 195cm
Catalog Number
7-10050-01
Brand Name
ZILIENT
Version/Model Number
12G-195-014
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"
-
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
MCW
Product Code Name
Catheter, Peripheral, Atherectomy
Public Device Record Key
0c5be467-fbfa-44ea-a998-3f0b41b5ed25
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 02, 2018
Package DI Number
30852528005538
Quantity per Package
5
Contains DI Package
10852528005534
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |
| 3 | A medical device with high risk that requires premarket approval | 15 |