Catalog Number

-

Brand Name

Hygea Diode Laser

Version/Model Number

04778

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6764a06f-3fa2-4ce3-bdb6-e693c1d85c8e

Public Version Date

December 11, 2019

Public Version Number

1

DI Record Publish Date

December 03, 2019

Package DI Number

00872320004699

Quantity per Package

1

Contains DI Package

00872320004842

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit