Catalog Number

-

Brand Name

AHBP 2.5 gram

Version/Model Number

HBP-2512

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MTJ

Product Code Name

Wax,Bone

Public Device Record Key

52e877e5-c188-4c7f-a6db-089357f9e28c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 14, 2016

Package DI Number

10850391007075

Quantity per Package

12

Contains DI Package

00850391007078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-