Catalog Number

-

Brand Name

PROBE 404-NI Non-Invasive Angled Probe

Version/Model Number

PROBE 404-NI

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

K935495

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

663a8472-272e-429e-9365-41e0d7b159b4

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-