Catalog Number

352001

Brand Name

Falcon A Corning Brand

Version/Model Number

352001

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

2e674185-e4f2-4591-bdce-eb12e71368ce

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

December 02, 2020

Package DI Number

H1083520013

Quantity per Package

500

Contains DI Package

H1083520011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box