Catalog Number

-

Brand Name

dpl®

Version/Model Number

DPLNUVEAC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

a30e3d4f-bdf2-4ec3-bba7-84619e9d973b

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

B347DPLNUVEAC1

Quantity per Package

20

Contains DI Package

B347DPLNUVEAC0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-