Vitreoretinal Brush - Gentle brushing or manipulation of retina. Tip - HURRICANE MEDICAL INC

Duns Number:093377724

Device Description: Gentle brushing or manipulation of retina. Tip Length 3mm.

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More Product Details

Catalog Number

7523

Brand Name

Vitreoretinal Brush

Version/Model Number

7523

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

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 Details

Product Code

HMX

Product Code Name

Cannula, Ophthalmic

Device Record Status

Public Device Record Key

8e502750-cf66-4e51-950c-f7c5581e3bab

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HURRICANE MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75