Duns Number:832696038
Device Description: TEMNO CHIBA NEEDLE SETS COAXIAL 20G X20CM 5/CS
Catalog Number
CCH2020
Brand Name
Temno
Version/Model Number
CCH2020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 23, 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
5765513a-29b7-46f2-b714-d8dfed23018b
Public Version Date
January 24, 2022
Public Version Number
5
DI Record Publish Date
September 15, 2017
Package DI Number
50885403088733
Quantity per Package
5
Contains DI Package
10885403088735
Package Discontinue Date
January 23, 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 |