N/A - Reusable Iris Retractors - Optalmed, LLC

Duns Number:037077801

Device Description: Reusable Iris Retractors

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More Product Details

Catalog Number

30-254

Brand Name

N/A

Version/Model Number

30-254

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

HOC

Product Code Name

Clip, Iris Retractor

Device Record Status

Public Device Record Key

bff6cdab-87c4-4c9b-bf5b-a8ed9ccb367f

Public Version Date

March 18, 2021

Public Version Number

1

DI Record Publish Date

March 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OPTALMED, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6