Skip to content

BioZorb Marker F0404

by Focal Therapeutics GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851766006047 UDI-DIDate26 Oct 2015ListedStatusListed 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  • Withdrawn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
BioZorb Marker
Generic Name
Radiological image marker, implantable
Model / Reference
F0404
Description
The Marker is a radiographic implantable marker used to mark soft tissue. It is comprised of a bioabsorbable spacer that holds radiopaque marker clips.
Primary DI / UDI-DI
00851766006047
FDA Product Code
NEU
GMDN Term
Radiological image marker, implantable
Device Class
Class II
Regulation Number
878.4300
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 4 Centimeter
Width — 4 Centimeter

Other devices from Focal Therapeutics

Properties

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

Other properties (8)

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