Medium Prone Stander - Prone Stander - RIFTON EQUIPMENT

Duns Number:808251438

Device Description: Prone Stander

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More Product Details

Catalog Number

-

Brand Name

Medium Prone Stander

Version/Model Number

E940

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

KNL

Product Code Name

Board, Scooter, Prone

Device Record Status

Public Device Record Key

2f727579-0c53-41b0-8287-2313a046e0a2

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RIFTON EQUIPMENT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49