Duns Number:002348191
Device Description: UltraCath(TM) Continuous Nerve Block Kit
Catalog Number
UC-19611-KPU
Brand Name
ARROW
Version/Model Number
IPN048795
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162522,K162522
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
dbc0d30b-3b35-4856-b45a-14e79429aa78
Public Version Date
April 21, 2021
Public Version Number
3
DI Record Publish Date
November 09, 2018
Package DI Number
30801902134548
Quantity per Package
5
Contains DI Package
40801902134545
Package Discontinue Date
April 15, 2021
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 |