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Op.n™ Camera I01021

by Ecential Robotics

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 Number03701311501664 UDI-DI Date13 Sep 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  • Withdrawn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
Op.n™ Camera
Generic Name
Optical surgical navigation/tracking system
Model / Reference
I01021
Primary DI / UDI-DI
03701311501664
510(k) Number
FDA Product Code
OLO
GMDN Term
Optical surgical navigation/tracking system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261113)

Show all (12)

Other devices from Ecential Robotics

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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