Catalog Number

AS78251

Brand Name

E1 Handpiece, LT

Version/Model Number

AS78251

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

K061966

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

e14934e1-925b-4a92-836b-39a2fcfbaabc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-