Catalog Number

-

Brand Name

HOLLYWOOD SPECTRA

Version/Model Number

HOLLYWOOD SPECTRA OP

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

25d4cf75-1c51-47d0-aabf-ffc24473a806

Public Version Date

July 26, 2021

Public Version Number

2

DI Record Publish Date

January 26, 2021

Package DI Number

08809447654782

Quantity per Package

1

Contains DI Package

08809447654676

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden Box