Duns Number:071595540
Device Description: CUDA, Bendable to 45 Degree
Catalog Number
A9350
Brand Name
CUDA
Version/Model Number
A9350
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
f4476ec1-53da-432f-b41c-b47dcfd6b280
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
December 01, 2020
Package DI Number
20845854010263
Quantity per Package
6
Contains DI Package
10845854010266
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 |