Duns Number:031108704
Catalog Number
SCMBW-018V
Brand Name
Safari2 Extra Support
Version/Model Number
H74939597ESS1
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
e5e6031b-4277-4f28-b008-b18446ad4da3
Public Version Date
April 01, 2022
Public Version Number
1
DI Record Publish Date
March 24, 2022
Package DI Number
10816349012614
Quantity per Package
5
Contains DI Package
00816349012617
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 |