Duns Number:968903703
Device Description: STENT PRB35-07-120-080 PROTEGE EF V10
Catalog Number
-
Brand Name
EverFlex
Version/Model Number
PRB35-07-120-080
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
P110023
Product Code
NIP
Product Code Name
STENT, SUPERFICIAL FEMORAL ARTERY
Public Device Record Key
6ee1d927-6a7b-4714-aae0-39864daaa393
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
May 27, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |