Catalog Number

-

Brand Name

MAI

Version/Model Number

81446

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

-

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

-

FDA Premarket Submission

-

Product Code

FTN

Product Code Name

Plastic surgery and accessories kit

Public Device Record Key

8919af7c-ca40-4027-86a0-9f53fb8fb751

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

November 05, 2020

Package DI Number

20809160295141

Quantity per Package

10

Contains DI Package

10809160295144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-