Catalog Number

-

Brand Name

XVS STERILE COMPONENTS KIT

Version/Model Number

ASP00014

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

K190929,K190929,K190929

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

4eda0a05-9537-4322-8023-3980a26c32c2

Public Version Date

March 24, 2020

Public Version Number

1

DI Record Publish Date

March 16, 2020

Package DI Number

17290113780108

Quantity per Package

1

Contains DI Package

07290113780101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch