Catalog Number

-

Brand Name

Reprocessed Apollo RF Aspirating Ablator 90, Multi Port

Version/Model Number

AR-9811

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2021

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

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

-

Product Code

NBH

Product Code Name

Accessories, Arthroscopic

Public Device Record Key

b2afdc77-9e40-4e54-8b5e-5656346b603a

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

October 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-