Duns Number:202738675
Device Description: OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22GA.), 54MM L OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED HYBRID CANNULA (22GA.), 54MM LONG, 4MM BARE TIP
Catalog Number
DHC-022/54/4-SC
Brand Name
OWL
Version/Model Number
DHC-022/54/4-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
16fa3bd9-ba37-48aa-ad83-12c23063aaa4
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
00825114007949
Quantity per Package
10
Contains DI Package
00825114007932
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 |