RUBEX - AG, ULTRA STAIRLIFT - HARMAR SUMMIT, LLC

Duns Number:144008062

Device Description: AG, ULTRA STAIRLIFT

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More Product Details

Catalog Number

100-2N10-AD

Brand Name

RUBEX

Version/Model Number

AG300

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

PCD

Product Code Name

Powered stairway chair lift

Device Record Status

Public Device Record Key

538c2c63-ce2e-4b64-aa8a-2b4f6745751f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARMAR SUMMIT, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 544