Catalog Number

-

Brand Name

SOL-M Syringe

Version/Model Number

P180003

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

88ab7c4e-6972-4a73-8192-6bb6ed8c589f

Public Version Date

April 30, 2019

Public Version Number

1

DI Record Publish Date

April 22, 2019

Package DI Number

20818392018176

Quantity per Package

8

Contains DI Package

10818392018179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case