Catalog Number

6-54-100-10

Brand Name

INTEGRA 3

Version/Model Number

Integra 3 Thermosafe Leica DMi 2 x SAS

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

-

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

K003142

Product Code

MQJ

Product Code Name

Micromanipulators and microinjectors, assisted reproduction

Public Device Record Key

3f28bfd0-0364-4fa5-af25-6bf252b8f40e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-