Catalog Number

PDG-AIM-015

Brand Name

Geminus

Version/Model Number

AIMing Guides, 1.5mm

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

K111620

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

4a55df9e-f7da-4663-902b-fae4d298695e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-