Catalog Number

SurgiCase Connect

Brand Name

SurgiCase

Version/Model Number

SurgiCase Connect

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 2017

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113599

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

cfb0e6b2-49f8-45b1-b53c-13bb78e3a82c

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

February 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-