Catalog Number

-

Brand Name

Montage Flowable 8cc

Version/Model Number

OS-MON-1501FL

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

K193052

Product Code

MTJ

Product Code Name

Wax, Bone

Public Device Record Key

f4f09127-623b-4c89-9516-bf26e350af6f

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

February 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-