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