Catalog Number

DYNJZMEG0014M

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJZMEG0014M

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

K081791,K081791

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

d39868b4-df46-4851-b815-273c9228d7be

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40193489827188

Quantity per Package

12

Contains DI Package

10193489827187

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE