Catalog Number

-

Brand Name

XVS STERILE COMPONENTS KIT

Version/Model Number

ASP00050

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

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

bb61f93b-db22-4214-bb2d-1205857cb1e8

Public Version Date

October 14, 2022

Public Version Number

2

DI Record Publish Date

September 05, 2021

Package DI Number

17290113780986

Quantity per Package

10

Contains DI Package

07290113780989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Box Set