Duns Number:689484322
Device Description: The Optimos™ Snare is designed to be used for without diathermic energy for the endoscopic The Optimos™ Snare is designed to be used for without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract.
Catalog Number
KSN22FHC-20
Brand Name
Optimos™ Snare
Version/Model Number
KSN22FHC-20
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"
-
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
FGX
Product Code Name
Snare, Non-Electrical
Public Device Record Key
54495042-4ac7-4a5f-a63c-da4814464336
Public Version Date
August 25, 2022
Public Version Number
1
DI Record Publish Date
August 17, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 232 |