OmniBone Charger

GUDID 00810563023053

Varian Medical Systems, Inc.

Bone/joint surgical power tool motorized handpiece/set, electric, reusable

• Primary Device ID: 00810563023053
• NIH Device Record Key: 46f3b0a5-03c8-4ae3-9208-6b4062dd4c08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniBone Charger
• Version Model Number: SP-002-8F
• Company DUNS: 118097024
• Company Name: Varian Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00810563023053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230015

FDA Product Code

• KNW: Instrument, biopsy

Sterilization

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

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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