Duns Number:031108704
Catalog Number
-
Brand Name
SAFARI2™
Version/Model Number
H74939406S0
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
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
f4040686-1068-4adf-abfa-1ce008a956b3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 2016
Package DI Number
08714729887591
Quantity per Package
5
Contains DI Package
08714729887607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 151 |
| 3 | A medical device with high risk that requires premarket approval | 8 |