Catalog Number

ESRK3000

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

ESRK3000

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)

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

4b7e7f84-1aeb-4215-bd1e-bed9c1f82e69

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Package DI Number

30080196775976

Quantity per Package

25

Contains DI Package

10080196775972

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX