FDA.reportPublic FDA data

Sirius Pintuition

Primary DI
08719992742974
Brand
Sirius Pintuition
Company
Sirius Medical Systems B.V.
Model
Sirius Pintuition Probe
Catalog number
SPP
Device description
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.
Published
2024-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable
PBYTemporary Tissue Marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2
PBYTemporary Tissue MarkerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719992742974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719992742974087199927429748719992742974

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
492239438
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719992742516Sirius PintuitionSirius Pintuition Bracket Packet 14G x 12cmSPBP122024-11-22
08719992742509Sirius PintuitionSirius Pintuition Bracket Packet 14G x 12cmSPBP122024-11-22
08719992742530Sirius PintuitionSirius Pintuition Bracket Packet 14G x 7cmSPBP072024-11-22
08719992742592Sirius PintuitionSirius Pintuition Slim ProbeSPP22024-11-22
08719992742882Sirius PintuitionSirius Pintuition Seed 14G x 7cmSPS072024-11-22
08719992742943Sirius PintuitionSirius Pintuition Seed 14G x 12cmSPS122024-11-22
08719992742998Sirius PintuitionSirius Pintuition Base UnitSPBU2024-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450392850SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392867SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392874SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392881SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392935SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392942SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392959SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392966SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
10851674008574SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008581SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008598SmartClipElucent Medical, Inc.NEU2026-02-16
10851674008604SmartClip SecureElucent Medical, Inc.NEU2026-02-16
10851674008468SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008475SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008482SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008499SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008505SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008512SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008529SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008536SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008543SmartClipElucent Medical, Inc.NEU2025-10-01
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
00801741226342UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
08719992742516Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742516Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
08719992742998Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22