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VisAR 3.0.67

by Novarad Corporation

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB109VISAR30670 UDI-DIDate11 Dec 2025ListedStatusListed 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  • Withdrawn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
VisAR
Generic Name
Surgical planning/navigation-enhancement system
Model / Reference
VisAR 3.0.67
Primary DI / UDI-DI
B109VISAR30670
510(k) Number
FDA Product Code
OLO, LLZ
GMDN Term
Surgical planning/navigation-enhancement system
Device Class
Class II
Regulation Number
882.4560, 892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K220146)

Other devices from Novarad Corporation

See all devices from Novarad Corporation →

Properties

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