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Instrument Registration Platform Cover FPIR0211

by Brain Navi Biotechnology Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719878694001 UDI-DIDate25 Jul 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  • Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name
Instrument Registration Platform Cover
Generic Name
Stereotactic neuronavigation/planning system
Model / Reference
FPIR0211
Primary DI / UDI-DI
04719878694001
510(k) Number
FDA Product Code
HAW
GMDN Term
Stereotactic neuronavigation/planning system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Related devices

Cleared under the same submission (K242575)

Show all (12)

Other devices from Brain Navi Biotechnology Co., Ltd.

See all devices from Brain Navi Biotechnology Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No