Duns Number:002348191
Device Description: Bipolar Electrode Catheter with shrouded pins
Catalog Number
AI-05210-S
Brand Name
ARROW
Version/Model Number
IPN919926
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
K945229,K945229,K945229
Product Code
DRF
Product Code Name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Public Device Record Key
37ad32f5-6a83-4138-8e5d-e61d66308500
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
30801902198250
Quantity per Package
1
Contains DI Package
10801902198256
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 |