Duns Number:202738675
Device Description: OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED CANNULA (20 Ga.), 54mm LONG, 1 OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED CANNULA (20 Ga.), 54mm LONG, 10MM BARE TIP
Catalog Number
466-020/54/10-SC
Brand Name
OWL
Version/Model Number
466-020/54/10-SC
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"
-
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
K102566,K102566
Product Code
GXI
Product Code Name
Probe, Radiofrequency Lesion
Public Device Record Key
5afc8170-c1a6-438c-a48a-b4b09887fcc8
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
October 03, 2016
Package DI Number
00825114008526
Quantity per Package
10
Contains DI Package
00825114008519
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |