Catalog Number

71692803

Brand Name

TRIGEN

Version/Model Number

71692803

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100107

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

c7341f37-ba8f-4041-ab7e-57e27f2c2316

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-