Duns Number:174262477
Device Description: INTRODUCER,KIT 4FR X 11CM WITH .018X45CM SS/SS WIRE 21GX7CM NEEDLE
Catalog Number
525-079
Brand Name
STRADIS
Version/Model Number
525-079
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 04, 2016
Issuing Agency
In HIBCC
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
DRE
Product Code Name
Dilator, Vessel, For Percutaneous Catheterization
Public Device Record Key
7c453ea0-a78d-456d-8bf7-a5d24f6268fb
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
May 04, 2016
Package DI Number
M7525250793
Quantity per Package
50
Contains DI Package
M7525250791
Package Discontinue Date
May 04, 216
Package Status
Not 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 | 1226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
| U | Unclassified | 10 |