Duns Number:202738675
Device Description: OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 54mm LONG, 2mm BARE OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22 Ga.) 54mm LONG, 2mm BARE TIP
Catalog Number
DHC-022/54/2
Brand Name
OWL
Version/Model Number
DHC-022/54/2
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
927b9410-e65d-4343-90e9-a9e942cea87d
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
00825114007741
Quantity per Package
10
Contains DI Package
00825114007734
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 |