Catalog Number

-

Brand Name

Perc Pin 150mm 5 units Package

Version/Model Number

AMCH07015

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

K211188,K211188,K211188,K211188

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

63702512-811a-4db5-8225-5b9451a7578b

Public Version Date

August 13, 2021

Public Version Number

1

DI Record Publish Date

August 05, 2021

Package DI Number

27290113780921

Quantity per Package

20

Contains DI Package

17290113780924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 20 units