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Planning Station - USA 164063

by Medtech LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024704213 UDI-DIDate23 Feb 2026ListedStatusListed GUDID: 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  • Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name
Planning Station - USA
Generic Name
Multi-purpose stereotactic surgery system
Model / Ref / Catalog
164063, ROSAS00503
Primary DI / UDI-DI
00889024704213
510(k) Number
FDA Product Code
HAW
GMDN Term
Multi-purpose stereotactic surgery system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K231103)

Show all (12)

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