Catalog Number

-

Brand Name

Intelligent ICSI Micropipette

Version/Model Number

IC.2.50.xx.D

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

9136604c-e6db-4563-85d7-ec554498affc

Public Version Date

November 28, 2019

Public Version Number

1

DI Record Publish Date

November 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-