Duns Number:002348191
Device Description: StimuQuik(R) Insulated Peripheral Nerve Block Needle
Catalog Number
AB-22025-SS
Brand Name
ARROW
Version/Model Number
IPN921060
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
K173321,K173321
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
e911cee0-561e-43a6-a43b-eeed4fed1bf4
Public Version Date
March 28, 2022
Public Version Number
1
DI Record Publish Date
March 18, 2022
Package DI Number
10801902199635
Quantity per Package
25
Contains DI Package
20801902199632
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |