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Invisia™ SerenaSeat™ Polymer, 18" Wide, Grey Seat, White Frame INV-WSPE-18-GRY-WHT

by Healthcraft Products Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00689281037631 UDI-DI Date29 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Invisia™ SerenaSeat™ Polymer, 18" Wide, Grey Seat, White Frame
Generic Name
Shower seat, non-powered
Model / Ref / Catalog
INV-WSPE-18-GRY-WHT, 03763
Primary DI / UDI-DI
00689281037631
FDA Product Code
IKX
GMDN Term
Shower seat, non-powered
Device Class
Class I
Regulation Number
890.5050
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket Exempt

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No