Catalog Number

SYINS531

Brand Name

Rospital Productos Medicos

Version/Model Number

SYINS531

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

K110421,K110421,K110421

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

e4a1473a-ccb5-4211-951d-df2358abee29

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 18, 2020

Package DI Number

10812460026806

Quantity per Package

100

Contains DI Package

00812460026809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER BOX