Duns Number:329515725
Device Description: Kit for peripheral nerve blocks
Catalog Number
06050-21
Brand Name
Temena
Version/Model Number
06050-21
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAZ
Product Code Name
Anesthesia Conduction Kit
Public Device Record Key
a29bf361-9eb0-4c0e-9a57-0b3cb0ba0890
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
November 28, 2017
Package DI Number
03700339704064
Quantity per Package
10
Contains DI Package
03700339714063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 144 |