OmniBone Bone Biopsy Kit with 11 Gauge 158mm length

Basic Information

• Brand Name: OmniBone Bone Biopsy Kit with 11 Gauge 158mm length
• Primary DI: 00810563022742
• Version / Model: OMB 11/15
• Company Name: Varian Medical Systems, Inc.
• Labeler DUNS: 118097024
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-18
• Public Version: 2
• Public Version Date: 2025-10-06
• Public Version Status: Update
• Public Device Record Key: fe2ddc19-3afc-412c-b06d-692396c9ab09

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KNW	Instrument, biopsy	Gastroenterology, Urology	876.1075	2

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	10810563022749	GS1		5	In Commercial Distribution
Primary	00810563022742	GS1

Premarket Submissions

Submission Number	Supplement Number
K230015	000