Duns Number:140727624
Device Description: Fine Needle Aspiration Tray with 18ga x 7cm Techna-Cut™ Biopsy Needle
Catalog Number
ASK7017A
Brand Name
Fine Needle Aspiration Tray
Version/Model Number
ASK7017A
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
OJT
Product Code Name
Aspiration Tray
Public Device Record Key
1270aff9-2673-4a8c-b45e-7e16bcc77560
Public Version Date
July 27, 2022
Public Version Number
1
DI Record Publish Date
July 19, 2022
Package DI Number
20886333220964
Quantity per Package
10
Contains DI Package
00886333220960
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |