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Klarity Medical R332-S424C-R

by Klarity Medical Products, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00840510400446 UDI-DI Date25 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Klarity Medical
Generic Name
Patient positioning thermoplastic mould material
Model / Reference
R332-S424C-R
Primary DI / UDI-DI
00840510400446
510(k) Number
FDA Product Code
IYE
GMDN Term
Patient positioning thermoplastic mould material
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K022708)

Show all (12)

Other devices from Klarity Medical Products, LLC

See all devices from Klarity Medical Products, LLC →

Properties

  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • 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
  • Premarket Exempt: No
  • Serial Number: No