Duns Number:690543319
Device Description: SURFLASH Plus
Catalog Number
-
Brand Name
SURFLASH
Version/Model Number
SR*FVP2225
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 29, 2018
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
3b6fbd6f-4b1f-4c82-8be8-a6b24f1315be
Public Version Date
September 14, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
54987350709764
Quantity per Package
4
Contains DI Package
34987350709760
Package Discontinue Date
August 29, 2018
Package Status
Not 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |