Catalog Number

550058

Brand Name

JAZZ System

Version/Model Number

Puller Forceps

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OWI

Product Code Name

Bone Fixation Cerclage, Sublaminar

Public Device Record Key

7c689b18-b854-4702-98f1-008ce9657122

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

May 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-