Phantom

GUDID B214OSPTM3

medimaps group SA

Bone densitometry ultrasound phantom, test object

• Primary Device ID: B214OSPTM3
• NIH Device Record Key: 6da5bd10-c978-43db-91af-e1c7d53b0bf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phantom
• Version Model Number: 3
• Company DUNS: 486330728
• Company Name: medimaps group SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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
HIBCC	B214OSPTM3 [Primary]

FDA Product Code

• KGI: Densitometer, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-04
• Device Publish Date: 2022-12-08

Devices Manufactured by medimaps group SA

• B214OSTBSIV400 - TBS iNsight: 2025-02-21 TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X
• B214OSPTM3 - Phantom: 2023-10-04
• B214OSPTM3 - Phantom: 2023-10-04