Catalog Number

-

Brand Name

MEDLINE BONEWAX YELLOW

Version/Model Number

DYNJBW25

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K791495,K791495

Product Code

MTJ

Product Code Name

WAX,BONE

Public Device Record Key

08752f37-a87e-4778-ae9b-66625f9fb57d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 22, 2015

Package DI Number

10848782005618

Quantity per Package

12

Contains DI Package

00848782005611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box