Catalog Number

6002-710-050

Brand Name

N/A

Version/Model Number

6002-710-050

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

-

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Public Device Record Key

0d4bf0a3-686d-4ec0-943e-609002d1b7c1

Public Version Date

August 03, 2022

Public Version Number

1

DI Record Publish Date

July 26, 2022

Package DI Number

37613327551939

Quantity per Package

8

Contains DI Package

07613327551938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack