Catalog Number

-

Brand Name

H-Pette with Blade (1000 pieces)

Version/Model Number

3612

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

GJG

Product Code Name

Pipette, Quantitative, Hematology

Public Device Record Key

8b3869e6-c06a-4956-8e3c-8df2592ec898

Public Version Date

January 22, 2021

Public Version Number

5

DI Record Publish Date

May 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-