Catalog Number

-

Brand Name

Paxos Scope

Version/Model Number

40806

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

PJZ

Product Code Name

Camera, Ophthalmic, General-Use

Public Device Record Key

f0a3c723-0d5b-4c2f-8f7a-89f81c9d91d3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-