Duns Number:968903703
Device Description: STENT PRB35-06-080-120 PROTEGE EF V09
Catalog Number
-
Brand Name
EverFlex
Version/Model Number
PRB35-06-080-120
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 03, 2015
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
FGE
Product Code Name
Stents, drains and dilators for the biliary ducts
Public Device Record Key
f331afe4-ba73-454f-9025-0a22cfc2b06f
Public Version Date
April 08, 2022
Public Version Number
6
DI Record Publish Date
May 26, 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 |