Duns Number:027680821
Device Description: Snares are intended to be used with snare gun for removal of tonsil and nasal polyps.
Catalog Number
-
Brand Name
Richard-Allan® Nasal Snare
Version/Model Number
2406
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KBE
Product Code Name
SNARE, NASAL
Public Device Record Key
e7344caa-afa4-4b89-9bea-e6ce196736fd
Public Version Date
March 04, 2021
Public Version Number
3
DI Record Publish Date
December 04, 2018
Package DI Number
10887761005577
Quantity per Package
50
Contains DI Package
00887761005570
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |