Duns Number:079506014
Device Description: 4F REGULAR MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE, 7CM NEEDLE
Catalog Number
JT080400003
Brand Name
MICRO-STICK SET
Version/Model Number
JT080400003
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
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
23681e98-6c0f-4ef0-8e17-24f6854feebf
Public Version Date
August 06, 2018
Public Version Number
1
DI Record Publish Date
July 05, 2018
Package DI Number
50810988021417
Quantity per Package
40
Contains DI Package
30810988021413
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |