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Edge applicators 499-AP-MRA-4, 499-AP-MRA-5

by BTL Industries, 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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB108499AP1MRA45MUS00 UDI-DI Date20 Oct 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  • Withdrawn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
Edge applicators
Generic Name
Multi-modality hyperthermia system
Model / Reference
499-AP-MRA-4, 499-AP-MRA-5
Primary DI / UDI-DI
B108499AP1MRA45MUS00
FDA Product Code
GEI, PBX
GMDN Term
Multi-modality hyperthermia system
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
In Commercial Distribution

Other devices from BTL Industries, Inc.

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Properties

  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No