Duns Number:079375431
Device Description: ON-Q* Pain Relief System T-bloc* Echogenic Continuous Stimulating Nerve Block Set
Catalog Number
TB050ST
Brand Name
AVANOS
Version/Model Number
40791
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
d0e5420a-d547-40e7-83e1-68d7b5aa7fa9
Public Version Date
November 23, 2020
Public Version Number
2
DI Record Publish Date
July 03, 2020
Package DI Number
10193494407916
Quantity per Package
5
Contains DI Package
00193494407919
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 |