Catalog Number

76211

Brand Name

AMD-RITMED

Version/Model Number

76211

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)

Yes

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

ae95ea97-64aa-4f16-8dca-9e5739042a4f

Public Version Date

June 14, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

10686864041099

Quantity per Package

20

Contains DI Package

10686864040849

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER BOX