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2D X-Ray Leksell Frame Regst Plates 174015

by Medtech LLC GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760244031044 UDI-DIDate27 Jul 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
2D X-Ray Leksell Frame Regst Plates
Generic Name
Multi-purpose stereotactic surgery system
Model / Ref / Catalog
174015, ROSAS00345
Primary DI / UDI-DI
03760244031044
FDA Product Code
HAW
GMDN Term
Multi-purpose stereotactic surgery system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Unsafe

Other devices from Medtech LLC

See all devices from Medtech LLC →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • 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
  • Manufacturing Date: No