Catalog Number

8-000-7520/5

Brand Name

75mm Plastic-crit Plain

Version/Model Number

8-000-7520

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

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

GHY

Product Code Name

HEMATOCRIT, TUBE, RACK, SEALER, HOLDER

Public Device Record Key

9dbde481-358f-44f6-9ad5-a0da2124e018

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

July 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-