Catalog Number

PWR-2011S/A

Brand Name

DFINE®

Version/Model Number

00884450296530

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

-

Product Code

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

4ad48f33-095b-4054-a1e4-0575ea8b965f

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 21, 2018

Package DI Number

10884450296537

Quantity per Package

80

Contains DI Package

00884450296530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-