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Proxcelan™ Cs-131 Preloaded Mick® Cartridges - Non Sterile PL-4NS

by Isoray Medical, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 NumberM748PL4NS0 UDI-DI Date28 Oct 2015ListedStatusListed GUDID: not 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  • Withdrawn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
Proxcelan™ Cs-131 Preloaded Mick® Cartridges - Non Sterile
Generic Name
General-purpose brachytherapy system applicator, manual
Model / Reference
PL-4NS
Primary DI / UDI-DI
M748PL4NS0
FDA Product Code
KXK
GMDN Term
General-purpose brachytherapy system applicator, manual
Device Class
Class II
Regulation Number
892.5730
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

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

Other properties (9)

  • Sterile: 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