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Miami-Style Applicator Set, Varian (Non-CT/MR) 0104

by Mick Radio Nuclear Instrument, Inc EUDAMEDGUDID

Active European Union

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00817330020017 UDI-DIDate14 Oct 2016ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Miami-Style Applicator Set, Varian (Non-CT/MR)
Generic Name
General-purpose brachytherapy system applicator, manual
Model / Ref / Catalog
0104
Primary DI / UDI-DI
00817330020017
510(k) Number
FDA Product Code
JAQ
GMDN Term
General-purpose brachytherapy system applicator, manual
Device Class
Class II
Regulation Number
892.5700
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Related devices

Category: General-purpose brachytherapy system applicator, manual

Cleared under the same submission (K020176)

Show all (12)

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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