Catalog Number

MBS-2210

Brand Name

VYGON

Version/Model Number

MBS-2210

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

7e029862-d33a-4a56-9bad-62c73c07166c

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

August 16, 2016

Package DI Number

38498840006857

Quantity per Package

12

Contains DI Package

08498840006856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-