Catalog Number

-

Brand Name

Sunbiotec

Version/Model Number

MZD-10-20

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

-

Product Code

PUC

Product Code Name

Microtools, Assisted Reproduction (Pipettes), Exempt

Public Device Record Key

98352716-5e0a-4838-affe-037384c91595

Public Version Date

September 10, 2019

Public Version Number

2

DI Record Publish Date

June 19, 2019

Package DI Number

36970299143953

Quantity per Package

10

Contains DI Package

16970299143959

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-