Duns Number:344007369
Device Description: FTRD application cap for verification of possible application of the gastroduodenal FTRD® FTRD application cap for verification of possible application of the gastroduodenal FTRD® Set and diagnostic FTRD® Set (accessability and ability to pull lesion into the cap).
Catalog Number
200.77
Brand Name
gastroduodenal FTRD prOVE Cap
Version/Model Number
FTRD 13
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"
Yes
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
FEI
Product Code Name
Instrument, Special Lens, For Endoscope
Public Device Record Key
28fb62bc-f9d2-425a-9c1d-758bb5b09ddd
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 05, 2020
Package DI Number
04260206311164
Quantity per Package
2
Contains DI Package
04260206311171
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
folding box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |