Duns Number:079375431
Device Description: ECHOBRIGHT* Echogenic Single Shot Tuohy Needle with Stimulating Cable
Catalog Number
EBL18050TGC
Brand Name
AVANOS
Version/Model Number
47266
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
46b73044-fd5a-4f7e-a4ae-e70adcc4ea81
Public Version Date
November 23, 2020
Public Version Number
2
DI Record Publish Date
July 03, 2020
Package DI Number
10193494472662
Quantity per Package
10
Contains DI Package
00193494472665
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 269 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |