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IceSeed® Prostate Cryoablation Kit / SeedNet® System FPRPR3008

by Galil Medical Ltd

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 Number07290104830068 UDI-DI Date15 Aug 2016ListedStatusListed 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  • Withdrawn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
IceSeed® Prostate Cryoablation Kit / SeedNet® System
Generic Name
Cryosurgical set
Model / Ref / Catalog
FPRPR3008
Primary DI / UDI-DI
07290104830068
FDA Product Code
GEH
GMDN Term
Cryosurgical set
Device Class
Class II
Regulation Number
878.4350
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Galil Medical Ltd

See all devices from Galil Medical Ltd →

Properties

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

Other properties (6)

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