Duns Number:079375431
Device Description: PROBLOC* II Insulated Regional Block Needle with Injection Set and Stimulating Cable
Catalog Number
HN3S-100
Brand Name
AVANOS
Version/Model Number
32759
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
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
56d38261-4210-4b58-849b-bede15e6b9eb
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
July 03, 2020
Package DI Number
10193494327597
Quantity per Package
10
Contains DI Package
00193494327590
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 |