Invisia™ SerenaSeat™ Pro - The Serena-Seat is a high quality, commercial - Healthcraft Products Inc.

Duns Number:252468293

Device Description: The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Sea

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More Product Details

Catalog Number

03529

Brand Name

Invisia™ SerenaSeat™ Pro

Version/Model Number

INV-WSFD-18-MEDIUM-WHT

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)

-

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

0bac5fb2-7e68-4402-9ff7-bfc53c61325d

Public Version Date

February 09, 2022

Public Version Number

1

DI Record Publish Date

February 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEALTHCRAFT PRODUCTS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 298