Catalog Number

MBS-2234

Brand Name

VYGON

Version/Model Number

MBS-2234

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K873957,K873957,K873957

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

91173e96-695f-43b1-911e-f47ba1932675

Public Version Date

April 02, 2020

Public Version Number

1

DI Record Publish Date

March 25, 2020

Package DI Number

50849884001292

Quantity per Package

21

Contains DI Package

30849884001298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-