Duns Number:058614483
Device Description: Cytology Brush
Catalog Number
-
Brand Name
superDimension
Version/Model Number
AKI00100-01
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"
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
FDX
Product Code Name
endoscopic cytology brush
Public Device Record Key
d5c06a65-b263-4f97-8b4d-49acac4a4efd
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20884521200460
Quantity per Package
10
Contains DI Package
10884521200463
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |