Catalog Number

-

Brand Name

ACDUAL applicator

Version/Model Number

AS120058

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

K153717,K153717

Product Code

ONF

Product Code Name

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Public Device Record Key

658603b1-2c2b-4008-b374-4563ec22a1c1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

07290016540567

Quantity per Package

1

Contains DI Package

07290016540451

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-