Biopsy Kit for 8G Vertebroplasty Needle Kit

Basic Information

• Brand Name: Biopsy Kit for 8G Vertebroplasty Needle Kit
• Primary DI: 04260277175634
• Version / Model: 10001574US
• Catalog Number: 03.702.222S
• Company Name: Möller Medical GmbH
• Labeler DUNS: 320405061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-04
• Public Version: 2
• Public Version Date: 2021-09-27
• Public Version Status: Update
• Public Device Record Key: 9852c5fc-081c-49bf-a5d7-98717c39d2a6

Device Description

The biopsy kit for the Synthes Vertecem / Vertecem V + system is a sterile packed kit for taking bone biopsies from the vertebral body.

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: 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
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56301	Vertebral bone biopsy needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of spinal bone percutaneously or during open surgery. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate vertebral bone with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260277175634	GS1