Duns Number:832696038
Device Description: TEMNO FRANSEEN NEEDLE SETS COAXIAL 22G X15CM
Catalog Number
CFR2215
Brand Name
Temno
Version/Model Number
CFR2215
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 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
GDF
Product Code Name
GUIDE, NEEDLE, SURGICAL
Public Device Record Key
07509c1a-1d76-4e3f-ad0b-88e2b7aefa29
Public Version Date
October 21, 2022
Public Version Number
5
DI Record Publish Date
September 15, 2017
Package DI Number
50885403088801
Quantity per Package
5
Contains DI Package
10885403088803
Package Discontinue Date
October 21, 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 |