XVS Headset IPD-68 LCD Display - AUGMEDICS LTD

Duns Number:600325755

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More Product Details

Catalog Number

-

Brand Name

XVS Headset IPD-68 LCD Display

Version/Model Number

AHMD681WLD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

OLO

Product Code Name

Orthopedic Stereotaxic Instrument

Device Record Status

Public Device Record Key

1d2205d4-7d5d-419f-afb2-1a4aa59a9b14

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

17290113780580

Quantity per Package

1

Contains DI Package

07290113780583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Box

"AUGMEDICS LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46