Catalog Number

438B1178

Brand Name

ContinuTrac™

Version/Model Number

S438B1178

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

K830332

Product Code

GZT

Product Code Name

RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Public Device Record Key

8117cea8-cb25-49dd-b4d4-16494dbca337

Public Version Date

October 25, 2022

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-