Catalog Number

11-4600

Brand Name

ALGERBRUSH CORNEAL RUST RING REMOVER

Version/Model Number

11-4600

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

-

Product Code

HOG

Product Code Name

Burr, Corneal, Battery-Powered

Public Device Record Key

0aeac0fb-324c-429f-ba29-4f3d7b5de9b2

Public Version Date

May 14, 2019

Public Version Number

3

DI Record Publish Date

September 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-