Catalog Number

0306553000

Brand Name

ACM

Version/Model Number

0306553000

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

-

Product Code

OAR

Product Code Name

Injector, vertebroplasty (does not contain cement)

Public Device Record Key

404b48fd-06ac-40c9-a148-b7a1e7d3b24b

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

34546540055393

Quantity per Package

6

Contains DI Package

04546540055392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack