Catalog Number

-

Brand Name

MH

Version/Model Number

34-100-00

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

508503b9-4299-4ea1-84ff-7cb315268ac3

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

September 15, 2020

Package DI Number

10850018327104

Quantity per Package

30

Contains DI Package

00850018327107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case