BioZorb Marker

Basic Information

• Brand Name: BioZorb Marker
• Primary DI: 00851766006016
• Version / Model: F0203
• Company Name: FOCAL THERAPEUTICS, INC.
• Labeler DUNS: 965352946
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-26
• Public Version: 6
• Public Version Date: 2024-02-12
• Public Version Status: Update
• Public Device Record Key: 4413210c-173e-4e69-8247-6822822980a9
• Distribution End Date: 2021-04-21

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	878.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40808	Radiological image marker, implantable	A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851766006016	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	2	Centimeter
Length	3	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature
• Type: Special Storage Condition, Specify
• Special Conditions: If temperature indicator has a black center, do not use product.