Catalog Number

405080

Brand Name

Harvey Surgical Assistant (HSA)

Version/Model Number

405080

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"

Yes

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

-

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

a309009b-951f-4e9a-8ebb-4cfcbef5d385

Public Version Date

March 21, 2022

Public Version Number

2

DI Record Publish Date

September 16, 2020

Package DI Number

10810832031137

Quantity per Package

3

Contains DI Package

00810832031130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box