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STAR Tumor Ablation Kit (5|10, Long) with PowerCURVE RF-0510L-01

by Dfine, Inc. 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850696006257 UDI-DI Date23 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  • Withdrawn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
STAR Tumor Ablation Kit (5|10, Long) with PowerCURVE
Generic Name
Radio-frequency ablation system
Model / Ref / Catalog
RF-0510L-01
Primary DI / UDI-DI
00850696006257
FDA Product Code
GEI
GMDN Term
Radio-frequency ablation system
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
Not in Commercial Distribution

Other devices from Dfine, Inc.

Properties

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

Other properties (8)

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