Rumex - Melles DSAEK PLK Scraper, Style 2, 90° Angle, - RUMEX INTERNATIONAL CORP.

Duns Number:041546137

Device Description: Melles DSAEK PLK Scraper, Style 2, 90° Angle, Length 125 mm, Titanium

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More Product Details

Catalog Number

13-155T

Brand Name

Rumex

Version/Model Number

13-155T

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

HND

Product Code Name

Spatula, Ophthalmic

Device Record Status

Public Device Record Key

6633ea35-e7bc-4b16-8aaa-83b2f300c6ac

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 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