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IsoLoc ISO-100

by Radiadyne, L.L.C.

IsoLoc ISO-100 is a prostate immobilization balloon catheter (FDA Class II; FDA product code PCT, Prostate Immobilizer Rectal Balloon) made by Radiadyne, L.L.C., listed in FDA GUDID since 31 Jan 2018 (UDI-DI 00851546007103), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851546007103 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
IsoLoc
Generic name
Prostate immobilization balloon catheter
Model / Ref / Catalog
ISO-100
Primary DI / UDI-DI
00851546007103
FDA product code
PCT
GMDN term
Prostate immobilization balloon catheter
Device class
Class II
Regulation number
892.5720
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Prostate immobilization balloon catheter

Similar devices

Other devices filed under FDA product code PCT (Prostate Immobilizer Rectal Balloon).

Other devices from Radiadyne, L.L.C.

See all devices from Radiadyne, L.L.C. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)