SCT 2000 - SCT 2000 shower change table, mesh cover, lying - Pressalit A/S

Duns Number:305656662

Device Description: SCT 2000 shower change table, mesh cover, lying surface 21.7'' x 65'', with safety rail an SCT 2000 shower change table, mesh cover, lying surface 21.7'' x 65'', with safety rail and water collection tray, foldable, white. Fixed height, wall-mounted

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More Product Details

Catalog Number

R8425218000

Brand Name

SCT 2000

Version/Model Number

R8425218

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

INT

Product Code Name

Plinth

Device Record Status

Public Device Record Key

79313a43-70cd-4c99-8eae-4eedd70eab66

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 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