Catalog Number

30616

Brand Name

Sugi

Version/Model Number

30616

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2022

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

Yes

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

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

4cfef0b7-014f-4228-a4a6-cc8004d91de1

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

March 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-