Rumex - "Flynn Scleral Depressor, For Depressing - RUMEX INTERNATIONAL CORP.

Duns Number:041546137

Device Description: "Flynn Scleral Depressor, For Depressing Pediatric Sclera, Length 90 mm, Round Titanium H "Flynn Scleral Depressor, For Depressing Pediatric Sclera, Length 90 mm, Round Titanium Handle"

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More Product Details

Catalog Number

16-115

Brand Name

Rumex

Version/Model Number

16-115

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)

-

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

HNX

Product Code Name

Depressor, Orbital

Device Record Status

Public Device Record Key

eb64d42e-5806-4c68-b69d-a9af1816d32c

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RUMEX INTERNATIONAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 834
2 A medical device with a moderate to high risk that requires special controls. 4