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PERL Localization Device, 16Ga x 11.5cm Needle R10

by Focal Therapeutics GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851766006245 UDI-DIDate16 Jul 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
PERL Localization Device, 16Ga x 11.5cm Needle
Generic Name
Radiological image marker, implantable
Model / Reference
R10
Primary DI / UDI-DI
00851766006245
FDA Product Code
GDF
GMDN Term
Radiological image marker, implantable
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe
Size
Needle Gauge — 16 Gauge

Other devices from Focal Therapeutics

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No