Iris Spatula - Barraquer iris spatula, 4 1/4" round handle - Medetz Surgical Instruments LLC

Duns Number:876570990

Device Description: Barraquer iris spatula, 4 1/4" round handle

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More Product Details

Catalog Number

-

Brand Name

Iris Spatula

Version/Model Number

12-21299

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HND

Product Code Name

Spatula, Ophthalmic

Device Record Status

Public Device Record Key

3bbd6be7-f1bf-4974-bfe8-1581025074ed

Public Version Date

March 11, 2022

Public Version Number

1

DI Record Publish Date

March 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDETZ SURGICAL INSTRUMENTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 120