Showering and changing table 1000 - Showering and changing table 1000, 120V, - Pressalit A/S

Duns Number:305656662

Device Description: Showering and changing table 1000, 120V, electrically height adjustable with wired remote Showering and changing table 1000, 120V, electrically height adjustable with wired remote control, 1800 mm, with safety rail, white

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More Product Details

Catalog Number

R8403000-93

Brand Name

Showering and changing table 1000

Version/Model Number

R8403

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

INQ

Product Code Name

Table, Powered

Device Record Status

Public Device Record Key

13035e6c-2e1a-456d-a86c-ae1bcc7372f1

Public Version Date

February 09, 2021

Public Version Number

2

DI Record Publish Date

June 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRESSALIT A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 319