Catalog Number

-

Brand Name

Micsafe

Version/Model Number

1

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

4a4ffac5-7796-4dba-bd58-eb5d4b98536b

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Package DI Number

16971911295087

Quantity per Package

100

Contains DI Package

06971911295080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX