Catalog Number

-

Brand Name

Surgical Instrument

Version/Model Number

111-229-R

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191972

Product Code

PBF

Product Code Name

Orthopaedic Surgical Planning And Instrument Guides

Public Device Record Key

7ec864f6-9b8f-454b-a8b7-3ba3fb609603

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

November 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-