Catalog Number

0400-205-000

Brand Name

NA

Version/Model Number

0400205000

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)

Yes

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

58618c7d-60e6-4b87-abd6-b92e43c88290

Public Version Date

April 16, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

34546540186790

Quantity per Package

36

Contains DI Package

04546540186799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack