Duns Number:832696038
Device Description: TEMNO FRANSEEN NEEDLE 20G X 10CM 10/CS
Catalog Number
FRA2010
Brand Name
Temno
Version/Model Number
FRA2010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 12, 2022
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
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
a458429a-805f-4f65-bedc-ed41f4ef38d5
Public Version Date
February 14, 2022
Public Version Number
5
DI Record Publish Date
September 15, 2017
Package DI Number
50885403089532
Quantity per Package
10
Contains DI Package
10885403089534
Package Discontinue Date
February 12, 2022
Package Status
Not 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |