Duns Number:825239189
Device Description: Endoscopic polypectomy snare, Medium Oval - Hot
Catalog Number
ET1801
Brand Name
ezSnare Polypectomy Snare
Version/Model Number
ET1801
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 26, 2021
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
KNS
Product Code Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Public Device Record Key
445af0d8-b6c2-46f5-8813-902c78f84877
Public Version Date
March 01, 2021
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
10816207020256
Quantity per Package
10
Contains DI Package
00816207020259
Package Discontinue Date
February 26, 2021
Package Status
Not in Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |