Duns Number:344007369
Device Description: Ovesco’s Traction Polypectomy Snare is a newly designed, serrated snare • for endoscopic Ovesco’s Traction Polypectomy Snare is a newly designed, serrated snare • for endoscopic procedures such as polypectomy, endoscopic mucosa resection (EMR) or similar techniques • specific design - attached teeth to the distal part of the loop - reduces slipping of the snare upon closure • excellent maneuverability and repositioning properties • monopolar high-frequency instrument
Catalog Number
200.55.10
Brand Name
Traction Polypectomy Snare
Version/Model Number
220 cm
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
K140923,K140923
Product Code
FDI
Product Code Name
Snare, Flexible
Public Device Record Key
fa4e60f5-20b9-46e0-ba17-7abe266c8016
Public Version Date
October 31, 2019
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
4260206310549
Quantity per Package
10
Contains DI Package
04260206310648
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 |