Duns Number:002348191
Device Description: StimuCath(R) Continuous Peripheral Nerve Block Set
Catalog Number
AB-05060
Brand Name
ARROW
Version/Model Number
IPN040009
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030937,K030937
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
3d68789c-af36-42ad-95aa-8e0bda8c18f9
Public Version Date
August 09, 2022
Public Version Number
7
DI Record Publish Date
August 30, 2017
Package DI Number
20801902124719
Quantity per Package
10
Contains DI Package
30801902124716
Package Discontinue Date
August 08, 2022
Package Status
Not 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 |