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

6ef602ed-f21b-4582-a2c9-7af1f140c5e3

Public Version Date

August 24, 2021

Public Version Number

1

DI Record Publish Date

August 16, 2021

Package DI Number

16971911295001

Quantity per Package

100

Contains DI Package

06971911295004

Package Discontinue Date

August 16, 2021

Package Status

Not in Commercial Distribution

Package Type

box