BIOPSYBELL

Basic Information

• Brand Name: BIOPSYBELL
• Primary DI: 08033860039493
• Version / Model: V-STRUT BONE FILLER
• Catalog Number: 32600
• Company Name: BIOPSYBELL SRL
• Labeler DUNS: 438746708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-22
• Public Version: 1
• Public Version Date: 2021-12-30
• Public Version Status: New
• Public Device Record Key: ce45b3ec-4559-4ca5-b9f5-2ec880563054

Device Description

KYPHOPLASTY BONE FILLER KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58032	Vertebral body cement cannula	A sterile, manual, tubular device designed to create a percutaneous access channel into a vertebral body prior to and during injection of orthopaedic cement into the vertebral body during kyphoplasty. It is typically inserted under fluoroscopic guidance to treat a patient diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine. The device is typically made of stainless steel with an attached plastic handle and available in a kit of several equal size cannulae (e.g., 3 or 6) to provide access to one or more sites of intervention. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08033860039509	GS1	BLISTER	10	In Commercial Distribution
Primary	08033860039493	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	2.30	Millimeter
Length	200	Millimeter
Needle Gauge	13	Gauge