Catalog Number

D7506

Brand Name

OWL

Version/Model Number

D7506

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

766559ae-1c28-4e92-8031-7e9edd885940

Public Version Date

February 01, 2022

Public Version Number

6

DI Record Publish Date

September 01, 2016

Package DI Number

00825114008427

Quantity per Package

50

Contains DI Package

00825114000483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX