Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

88-000102W

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

K130027,K130027,K130027

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

862c2454-9827-4247-8c9f-c1f8e173d3ba

Public Version Date

July 23, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

30749756886858

Quantity per Package

50

Contains DI Package

00749756886857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box