Rave - Rave-II - RH Folding Rail Without Track - HARMAR SUMMIT, LLC

Duns Number:144008062

Device Description: Rave-II - RH Folding Rail Without Track

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More Product Details

Catalog Number

Rave-II-FRRH-KNT

Brand Name

Rave

Version/Model Number

Rave-II

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

bfcd05c6-59c4-418c-a354-85bceac36a4e

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

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