PLUS - PLUS shower seat 450, 17.7'' x 17.2'', with - Pressalit A/S

Duns Number:305656662

Device Description: PLUS shower seat 450, 17.7'' x 17.2'', with aperture, incl. backrest and armrests, white. PLUS shower seat 450, 17.7'' x 17.2'', with aperture, incl. backrest and armrests, white. Electrically height adjustable, manually sideways adjustable, for fitting to horizontal wall track

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More Product Details

Catalog Number

R7865000

Brand Name

PLUS

Version/Model Number

R7865

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

INN

Product Code Name

Chair, Adjustable, Mechanical

Device Record Status

Public Device Record Key

a01ae9cb-f186-495d-b6a4-5de212f116c2

Public Version Date

June 22, 2021

Public Version Number

1

DI Record Publish Date

June 14, 2021

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