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LumenCare Azure 110685-03

by Nucletron B.V.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08717213059313 UDI-DI Date8 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LumenCare Azure
Generic Name
Bronchial brachytherapy system applicator, remote-afterloading
Model / Reference
110685-03
Primary DI / UDI-DI
08717213059313
510(k) Number
FDA Product Code
JAQ
GMDN Term
Bronchial brachytherapy system applicator, remote-afterloading
Device Class
Class II
Regulation Number
892.5700
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K262383)

Other devices from Nucletron B.V.

See all devices from Nucletron B.V. →

Properties

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

Other properties (9)

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