VSP Bolus VSPRT

GUDID 00816847022613

The 3D Systems VSP Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VSP Bolus is generated using input from radiation therapy professionals and medical imaging data to produce a bolus that is specific to the patient being treated. The VSP Bolus product is verified and approved by the radiation therapy professional prior to use on the patient, and is intended for patients of all ages receiving radiotherapy treatment. VSP Bolus was evaluated using 6 MV photons but has not been assessed for use with protons, electrons, or at orthovoltage X-rays.

3D SYSTEMS, INC.

Radiation therapy bolus, single-use

• Primary Device ID: 00816847022613
• NIH Device Record Key: eff78ea5-c5ed-4701-84fb-2e9ea282a2d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSP Bolus
• Version Model Number: 1.0
• Catalog Number: VSPRT
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, 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: false
• 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	00816847022613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214093

FDA Product Code

• IXI: Block, Beam-Shaping, Radiation Therapy

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: 2023-02-15
• Device Publish Date: 2023-02-07

Devices Manufactured by 3D SYSTEMS, INC.

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• 00816847022699 - Salto Talaris Chamfer Cut Total Ankle System: 2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022705 - Salto Talaris Chamfer Cut Total Ankle System: 2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022712 - Cadence Chamfer Cut Total Ankle System: 2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022729 - Cadence Chamfer Cut Total Ankle System: 2024-09-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022798 - Vantage 3D PSI: 2024-08-13 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an