Avitus Bone Harvester FI-100

GUDID 00857373006029

Filter Accessory for REF: BH8 ONLY

AVITUS ORTHOPAEDICS, INC.

Bone graft harvesting filter

• Primary Device ID: 00857373006029
• NIH Device Record Key: d3096b9a-3fc5-4aa3-a71f-336f8cbf82be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avitus Bone Harvester
• Version Model Number: FI-100
• Catalog Number: FI-100
• Company DUNS: 078269403
• Company Name: AVITUS ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857373006029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170539

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-07

On-Brand Devices [Avitus Bone Harvester]

• 00857373006050: A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti
• 00857373006036: A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting ti
• 00857373006029: Filter Accessory for REF: BH8 ONLY
• 00857373006005: A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting ti
• 00857373006074: Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone a