Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

88-100013C

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HGI

Product Code Name

ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

1b35e7e2-efa6-4a02-8e17-babe99d57c18

Public Version Date

August 25, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

50749756136162

Quantity per Package

100

Contains DI Package

00749756136167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case