Duns Number:627879687
Device Description: The Talon grasping device is used to retrieve of foreign bodies, tissue specimens, stones The Talon grasping device is used to retrieve of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
Catalog Number
00711175
Brand Name
Talon
Version/Model Number
00711175
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
07ef88ce-e4be-4390-8474-02fb90acf32c
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
March 19, 2020
Package DI Number
10724995182783
Quantity per Package
5
Contains DI Package
00724995182786
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 |