OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm

GUDID 10810563023036

VARIAN MEDICAL SYSTEMS, INC.

Bone marrow biopsy needle, single-use

• Primary Device ID: 10810563023036
• NIH Device Record Key: 537b1a79-6cdb-4d5a-970c-2b10247ac86d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm
• Version Model Number: OMM 11/15
• 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	00810563023039 [Primary]
GS1	10810563023036 [Package]; Contains: 00810563023039; 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

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