Catalog Number

ZPH1850

Brand Name

ZyMot

Version/Model Number

Multi 850 microL

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173075,K173075

Product Code

MQK

Product Code Name

Labware, Assisted Reproduction

Public Device Record Key

af8c65f7-ec18-4c05-9a45-01531206fd50

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-