Rumex - Reusable Tubing System For The Infusion Of - RUMEX INTERNATIONAL CORP.

Duns Number:041546137

Device Description: Reusable Tubing System For The Infusion Of Silicone Oil, Caprolon Adapter Adjustable To Lo Reusable Tubing System For The Infusion Of Silicone Oil, Caprolon Adapter Adjustable To Loltech® Pentasys; Optikon® Antares; Alcon® STTO; Storz® Premiere; DORC® Harmony Budget™

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More Product Details

Catalog Number

12-RTUB-1

Brand Name

Rumex

Version/Model Number

12-RTUB-1

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

GAZ

Product Code Name

Tubing, Noninvasive

Device Record Status

Public Device Record Key

6e90c626-3964-428c-a14c-62fcda106ee4

Public Version Date

June 19, 2020

Public Version Number

1

DI Record Publish Date

June 11, 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