Duns Number:316625425
Device Description: ARROWtip™ single-use electrode 230mm, Ø0.3mm, 90°angled, shaft Ø2.4mm UOM = 2 pi ARROWtip™ single-use electrode 230mm, Ø0.3mm, 90°angled, shaft Ø2.4mm UOM = 2 pieces single-use
Catalog Number
364474
Brand Name
Sutter
Version/Model Number
364474
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
-
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
351a5c10-a621-4dff-bf5c-17404a901e41
Public Version Date
July 25, 2022
Public Version Number
2
DI Record Publish Date
November 12, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 265 |