AccessGUDID - DEVICE: BioZorb Marker (00851766006009)

GUDID

Device Identifier (DI) Information

Brand Name: BioZorb Marker
Version or Model: F0202
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FOCAL THERAPEUTICS, INC.

Primary DI Number: 00851766006009
Issuing Agency: GS1
Commercial Distribution End Date: April 21, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 965352946 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NEU	Marker, Radiographic, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Centimeter
Width: 2 Centimeter

Device Record Status

Public Device Record Key: e4aa9041-22e5-4079-8040-95fe76714ba4
Public Version Date: February 12, 2024
Public Version Number: 6
DI Record Publish Date: October 26, 2015