Catalog Number

-

Brand Name

Perc Mallet 250 gr.

Version/Model Number

AMCH07700

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

K211188

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

0ed40869-2d78-46c1-abdf-3a5910b50bfd

Public Version Date

October 14, 2022

Public Version Number

3

DI Record Publish Date

August 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-