Catalog Number

2028

Brand Name

Corning®

Version/Model Number

2028

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

FMH

Product Code Name

CONTAINER, SPECIMEN, STERILE

Public Device Record Key

5af3554b-6f54-4e46-aeae-9608b383edb4

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 02, 2020

Package DI Number

H10820283

Quantity per Package

5

Contains DI Package

H10820281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box