Catalog Number

1155/A

Brand Name

DFINE®

Version/Model Number

00884450296158

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090986,K090986

Product Code

NDN

Product Code Name

CEMENT, BONE, VERTEBROPLASTY

Public Device Record Key

bc2cdad9-3802-4d87-811d-a174367cdb6a

Public Version Date

July 12, 2018

Public Version Number

1

DI Record Publish Date

June 11, 2018

Package DI Number

10884450296155

Quantity per Package

90

Contains DI Package

00884450296158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-