Catalog Number

93002

Brand Name

OXYSEPT

Version/Model Number

93002

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

LPN

Product Code Name

Accessories, Soft Lens Products

Public Device Record Key

55bc3dd5-a5a0-4e77-afbf-bdc3264b876e

Public Version Date

February 26, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10827444000147

Quantity per Package

6

Contains DI Package

00827444000140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box