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McLaren Range Shifter Null (TR1) A001228

by Mclaren Health Care Corporation

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 Number00850084890109 UDI-DI Date16 Jun 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  • Withdrawn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
McLaren Range Shifter Null (TR1)
Generic Name
Proton therapy system beam-delivery system
Model / Reference
A001228
Primary DI / UDI-DI
00850084890109
510(k) Number
FDA Product Code
LHN
GMDN Term
Proton therapy system beam-delivery system
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K160063)

Other devices from Mclaren Health Care Corporation

See all devices from Mclaren Health Care Corporation →

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