Catalog Number

-

Brand Name

StarBurst

Version/Model Number

700102331

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K983871,K983871

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

812ee8be-9f7c-47f9-b5ce-e21a10918a17

Public Version Date

August 27, 2018

Public Version Number

1

DI Record Publish Date

July 26, 2018

Package DI Number

H7877001023311

Quantity per Package

6

Contains DI Package

H7877001023310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX