Catalog Number

5176000068

Brand Name

CellTram® Air

Version/Model Number

5176000068

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 09, 2018

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

-

Product Code

MQJ

Product Code Name

Micromanipulators And Microinjectors, Assisted Reproduction

Public Device Record Key

60efc578-7241-4cae-b4d4-1944ac6ad3f6

Public Version Date

November 14, 2018

Public Version Number

4

DI Record Publish Date

February 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-