Duns Number:825239189
Device Description: Flexible Polypectomy Snare, Large Hexagonal - Hot
Catalog Number
SGH-1622L
Brand Name
Polypectomy Snare, Hexagonal
Version/Model Number
SGH-1622L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
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
5e0989dd-3f1e-4c9d-82c0-fc685a91ffb6
Public Version Date
November 05, 2019
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10816207020614
Quantity per Package
10
Contains DI Package
00816207020617
Package Discontinue Date
November 04, 2019
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 |