Catalog Number

-

Brand Name

SPECTRA

Version/Model Number

SPECTRA SL body U120V

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

8d22f1f4-ddc3-4ea3-b10c-e8e814074b08

Public Version Date

July 26, 2021

Public Version Number

4

DI Record Publish Date

July 27, 2016

Package DI Number

8809447650432

Quantity per Package

1

Contains DI Package

08809447650272

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Wooden box