Duns Number:002348191
Device Description: Continuous Peripheral Nerve Block Needle
Catalog Number
AB-00090
Brand Name
ARROW
Version/Model Number
IPN040003
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121403,K121403,K121403
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
b085bef6-b5f0-4024-9157-085c9a2d8d1b
Public Version Date
June 15, 2021
Public Version Number
6
DI Record Publish Date
December 22, 2016
Package DI Number
20801902124689
Quantity per Package
10
Contains DI Package
60801902124687
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |