Catalog Number

SFYN27

Brand Name

Rospital Productos Medicos

Version/Model Number

SFYN27

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

K190183,K190183,K190183

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

38094107-22d0-4728-95f3-c8b230af48e1

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Package DI Number

10812460027308

Quantity per Package

100

Contains DI Package

00812460027301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER