Catalog Number

-

Brand Name

XVS L-Headset IPD-64 Clear Display

Version/Model Number

AHMD642WLT

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

K190929,K190929

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Public Device Record Key

6b117965-faf1-4766-84d3-4899445d8979

Public Version Date

January 18, 2021

Public Version Number

1

DI Record Publish Date

January 10, 2021

Package DI Number

17290113780825

Quantity per Package

1

Contains DI Package

07290113780828

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box