CT 5000 - CT 5000 change table, lying surface in compact - Pressalit A/S

Duns Number:305656662

Device Description: CT 5000 change table, lying surface in compact laminate, 27.6 x 47.2'' , white. With safet CT 5000 change table, lying surface in compact laminate, 27.6 x 47.2'' , white. With safety rail and body belt, foldable, fixed height, wall-mounted

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More Product Details

Catalog Number

R8455512000

Brand Name

CT 5000

Version/Model Number

R8455512

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

bc8fd76c-1397-42f8-865b-508514c0ab16

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 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