Catalog Number

O-01-0-200000-0011-010

Brand Name

SurgiCase

Version/Model Number

O-01-0-200000-0011-010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K112389,K163156

Product Code

PBF

Product Code Name

Orthopaedic Surgical Planning And Instrument Guides

Public Device Record Key

2b2c61fe-cdfa-4bf2-b24a-f29592c34709

Public Version Date

November 27, 2019

Public Version Number

4

DI Record Publish Date

December 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-