OmniBone Bone Biopsy Kit with 11 Gauge 108mm length

GUDID 10810563022732

VARIAN MEDICAL SYSTEMS, INC.

Bone biopsy needle

• Primary Device ID: 10810563022732
• NIH Device Record Key: e2954725-7d53-4ab6-818b-c4aa60c3a4f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniBone Bone Biopsy Kit with 11 Gauge 108mm length
• Version Model Number: OMB11/10
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810563022735 [Primary]
GS1	10810563022732 [Package]; Contains: 00810563022735; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230015

FDA Product Code

• KNW: Instrument, biopsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-26
• Device Publish Date: 2025-09-18

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00810563022629 - Guiding tube 60 degrees ring for central needle: 2025-12-03
• 00816389028937 - Guided Aarhus Applicator Set: 2025-12-03
• 00816389028944 - Guided Aarhus vaginal template 60 degrees,ø 28 mm: 2025-12-03
• 00816389028951 - Guided Aarhus vaginal template 60 degrees, ø 32 mm: 2025-12-03
• 00816389028968 - Guided Aarhus vaginal template 60 degrees, ø 36 mm: 2025-12-03
• 00816389028975 - Guide tube collector for up to 7 needles: 2025-12-03
• 00816389028982 - Guide tube collector for up to 11 needles: 2025-12-03
• 10810563022725 - OmniBone Bone Biopsy Kit with 11 Gauge 68mm length: 2025-09-26