Catalog Number

-

Brand Name

Cenefom

Version/Model Number

OP-LR02

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082460,K082460

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

4b3bede1-9ffe-466f-86e5-e97bec5078c5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-