Catalog Number

-

Brand Name

IRIS RETRACTORS

Version/Model Number

S9.5015

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

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

HNQ

Product Code Name

Hook, Ophthalmic

Public Device Record Key

3cd12ea6-8bf5-4d34-b7c2-f3733ba2b704

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 29, 2021

Package DI Number

23700773724981

Quantity per Package

5

Contains DI Package

13700773724984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-