Catalog Number

-

Brand Name

Montage Flowable Syringe

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

a94557b2-0f5f-4d2a-9ffb-6f4c9bb42f21

Public Version Date

March 17, 2021

Public Version Number

1

DI Record Publish Date

March 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-