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CT/MR Universal Rectal Retractor 1209

by Mick Radio Nuclear Instrument, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00817330028013 UDI-DI Date15 May 2017ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2081-2008 FDA Unclassified (pre-2012) initiated 12 Mar 2008

    Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CT/MR Universal Rectal Retractor
Generic Name
General-purpose brachytherapy system applicator, manual
Model / Ref / Catalog
1209
Primary DI / UDI-DI
00817330028013
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 (K030110)

Show all (12)

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • 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
  • Expiration Date: No