Catalog Number

-

Brand Name

Accu-Beam

Version/Model Number

8019I

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FWL

Product Code Name

Camera, Cine, Endoscopic, Without Audio

Public Device Record Key

253c97b6-e135-4eb6-84b0-f495008a0b8d

Public Version Date

August 13, 2021

Public Version Number

3

DI Record Publish Date

August 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-