Catalog Number

DYNJZ11239

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJZ11239

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

K964176,K964176

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

4a58037c-e4e2-4959-a6f5-e4e2fd64eef5

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40888277804136

Quantity per Package

400

Contains DI Package

10888277804135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE