Catalog Number

-

Brand Name

Aquamantys(TM)

Version/Model Number

23-312-1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132974

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

830f152c-666a-4ff9-b248-a59a6da9e5aa

Public Version Date

August 08, 2018

Public Version Number

1

DI Record Publish Date

July 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-