Catalog Number

-

Brand Name

MAI

Version/Model Number

81381B

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

LRO

Product Code Name

General surgery tray

Public Device Record Key

73c80b82-3835-4dc6-9de1-e8aa7a3a30c7

Public Version Date

June 23, 2021

Public Version Number

1

DI Record Publish Date

June 15, 2021

Package DI Number

20809160352554

Quantity per Package

20

Contains DI Package

10809160352557

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-