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PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI Markers

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 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM748PL70 UDI-DI Date23 Apr 2021ListedStatusListed 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  • Withdrawn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

Generic Name
General-purpose brachytherapy system applicator, manual
Model / Reference
PL-7
Primary DI / UDI-DI
M748PL70
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
MRI Safety
MR Conditional

Other devices from Isoray Medical, Inc.

See all devices from Isoray Medical, Inc. →

Properties

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

Other properties (8)

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