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Dexalign™ Hand Positioner RT-5401

by Qfix

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841962120463 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Dexalign™ Hand Positioner
Generic Name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
RT-5401
Primary DI / UDI-DI
00841962120463
510(k) Number
FDA Product Code
IYE
GMDN Term
Indexed-immobilization patient positioning system
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K180021)

Show all (12)

Other devices from Qfix

See all devices from Qfix →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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