Duns Number:021717889
Device Description: Fully Covered OTW Stent System
Catalog Number
-
Brand Name
Agile™ Esophageal
Version/Model Number
M00517760
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
ESW
Product Code Name
PROSTHESIS, ESOPHAGEAL
Public Device Record Key
ba9b151a-a648-4f7e-9431-b6884c32fdb4
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 14, 2022
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 | 536 |
2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
3 | A medical device with high risk that requires premarket approval | 1821 |
U | Unclassified | 35 |