Duns Number:079375431
Device Description: ON-Q Pain Relief System QUIKBLOC* Over-the-Needle Catheter Set, Stimulating
Catalog Number
QB10016SGC
Brand Name
AVANOS
Version/Model Number
43057
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
b918bcdf-8f60-4c7b-91e5-3c35a53a2f6c
Public Version Date
November 23, 2020
Public Version Number
2
DI Record Publish Date
July 03, 2020
Package DI Number
10193494430570
Quantity per Package
5
Contains DI Package
00193494430573
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 |