Duns Number:071595540
Device Description: 3.7MM RHINOTEC GATOR, BENDABLE TO 30 DEG.
Catalog Number
E9361
Brand Name
RHINOTEC GATOR
Version/Model Number
E9361
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
EQJ
Product Code Name
BUR, EAR, NOSE AND THROAT
Public Device Record Key
20208307-c552-4f58-b706-490228c8e36d
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 12, 2021
Package DI Number
20845854009649
Quantity per Package
1
Contains DI Package
10845854009642
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |