Sirius Pintuition SPS07

GUDID 08719992742882

The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue. The Sirius Pintuition Detector is intended only for the non-imaging detection and localization of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

Sirius Medical Systems B.V.

Radiological image marker, implantable

• Primary Device ID: 08719992742882
• NIH Device Record Key: 3b172d82-3c33-4f44-8baf-03051f59beac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sirius Pintuition
• Version Model Number: Sirius Pintuition Seed 14G x 7cm
• Catalog Number: SPS07
• Company DUNS: 492239438
• Company Name: Sirius Medical Systems B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Dimensions

• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter
• Length: 7 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719992742585 [Package]; Package: white folding carton [10 Units]; In Commercial Distribution
GS1	08719992742882 [Primary]

FDA Product Code

• PBY: Temporary Tissue Marker

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: 2024-12-02
• Device Publish Date: 2024-11-22

On-Brand Devices [Sirius Pintuition]

• 08719992742998: The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 d
• 08719992742974: The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 d
• 08719992742943: The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 d
• 08719992742882: The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 d
• 08719992742592: The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 d
• 08719992742530: The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 d
• 08719992742509: The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 d