Catalog Number

3786

Brand Name

Corning

Version/Model Number

3786

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KJF

Product Code Name

SYSTEM, SUSPENSION, CELL CULTURE

Public Device Record Key

132b1af4-cec9-4397-a99f-70b20b45c27a

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 02, 2020

Package DI Number

H10837863

Quantity per Package

1

Contains DI Package

H10837861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-