SELECT TL4 - SELECT TL4 toilet bracket, for floor outlet, - Pressalit A/S

Duns Number:305656662

Device Description: SELECT TL4 toilet bracket, for floor outlet, prepared for shower toilet seat, 120V, white

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More Product Details

Catalog Number

R9134000

Brand Name

SELECT TL4

Version/Model Number

R9134

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

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

140710af-f22d-43f6-84a8-6a77ffb01164

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 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