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

ae17e7bb-fc70-4e3c-bb43-72b4db1b1304

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Package DI Number

16971911290273

Quantity per Package

100

Contains DI Package

06971911290276

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box