Catalog Number

-

Brand Name

ACU-GUARD

Version/Model Number

ADG51S

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K915000

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6b1bc146-abd2-41a5-89a1-7b4b950a8aca

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

January 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-