Catalog Number

MMSU1277S

Brand Name

Malosa Medical

Version/Model Number

MMSU1277S

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

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

HMQ

Product Code Name

Marker, Sclera

Public Device Record Key

25473feb-f59e-42c2-91b0-f10c0f1c4353

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-