Catalog Number

ROSAS00128

Brand Name

3D X-RAY PATTERN

Version/Model Number

ROSA3-144B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K182848,K192173

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

0ff274c9-4419-448c-b55f-5d218b136f60

Public Version Date

October 02, 2020

Public Version Number

3

DI Record Publish Date

December 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-