Duns Number:530269083
Device Description: Oval,Diameter of Snare is 10 mm, Outer tube is PE,diameter is 7Fr,working length is 2300mm Oval,Diameter of Snare is 10 mm, Outer tube is PE,diameter is 7Fr,working length is 2300mm,Non-Rotation Type
Catalog Number
-
Brand Name
MT
Version/Model Number
CS3-21023230
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
GAE
Product Code Name
Snare, Surgical
Public Device Record Key
e235a949-1cac-43aa-a40f-2d446f2db7b8
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
December 31, 2021
Package DI Number
16932503550038
Quantity per Package
10
Contains DI Package
06932503550031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |