Duns Number:627879687
Device Description: The Falcon rotatable retrieval basket is used to retrieve foreign bodies, tissue specimens The Falcon rotatable retrieval basket is used to retrieve foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
Catalog Number
00711141
Brand Name
Falcon
Version/Model Number
00711141
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
FGO
Product Code Name
DISLODGER, STONE, FLEXIBLE
Public Device Record Key
c42f23ba-f613-419b-8b47-6fca4571c97e
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
March 19, 2020
Package DI Number
10724995182660
Quantity per Package
5
Contains DI Package
00724995182663
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |