Catalog Number

-

Brand Name

AHBP Press

Version/Model Number

HBP-4010

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"

Yes

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

K140117,K140117

Product Code

MTJ

Product Code Name

Wax, Bone

Public Device Record Key

02fab90f-cc15-461b-98c7-bbf6240381ac

Public Version Date

February 22, 2021

Public Version Number

1

DI Record Publish Date

February 12, 2021

Package DI Number

10850391007099

Quantity per Package

10

Contains DI Package

00850391007092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-