Duns Number:071595540
Device Description: 4.2MM RHINOTEC CUDA, IRRIGATED
Catalog Number
N9210
Brand Name
RHINOTEC CUDA
Version/Model Number
N9210
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
6521c757-2c2b-4568-8062-3706ebb88e46
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 13, 2021
Package DI Number
20845854009472
Quantity per Package
1
Contains DI Package
10845854009475
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 |