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PainBuster

by Miessentia Medical USA LLC

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860003478103 UDI-DI Date20 Apr 2020ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Musculoskeletal infrared phototherapy unit, non-wearable
Model / Reference
Painbuster
Primary DI / UDI-DI
00860003478103
FDA Product Code
ILY
GMDN Term
Musculoskeletal infrared phototherapy unit, non-wearable
Device Class
Class II
Regulation Number
890.5500
GUDID distribution status
Not in Commercial Distribution

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No