Bonopty Penetration Set

Basic Information

• Brand Name: Bonopty Penetration Set
• Primary DI: 07350031350722
• Version / Model: 10-1072
• Catalog Number: 10-1072
• Company Name: Apriomed AB
• Labeler DUNS: 631734758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-04
• Public Version: 2
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: da90e923-62c3-478c-9284-2c8145a15815
• Distribution End Date: 2026-02-26

Device Description

Manually operated, sterile, single use coaxial bone biopsy system

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
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60477	Bone biopsy needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone, bone marrow and/or tumour from any bone of the body. It is typically inserted through a bone access cannula under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and supplied with an ejector rod to remove the biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17350031350729	GS1	Shelf box	5	Not in Commercial Distribution	2026-02-26
Primary	07350031350722	GS1
Package	27350031350726	GS1	Transportation box	12	In Commercial Distribution	2026-02-26

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	14	Gauge
Length	9.5	Centimeter