Catalog Number

005XEAE-4XL

Brand Name

Lac-Mac

Version/Model Number

005XEAE-4XL

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

K092344

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

685bacc3-2296-4b56-bd48-a3708f0e07e1

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-