FDA.reportPublic FDA data

Sirius Pintuition

Primary DI
08719992742530
Brand
Sirius Pintuition
Company
Sirius Medical Systems B.V.
Model
Sirius Pintuition Bracket Packet 14G x 7cm
Catalog number
SPBP07
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
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
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
08719992742523PackageGS15In Commercial Distribution
08719992742530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719992742523087199927425238719992742523
08719992742530087199927425308719992742530

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 radiological 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. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Regulatory Flags#

DUNS number
492239438
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719992742516Sirius PintuitionSirius Pintuition Bracket Packet 14G x 12cmSPBP122024-11-22
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
08719992742974Sirius PintuitionSirius Pintuition ProbeSPP2024-11-22
08719992742998Sirius PintuitionSirius Pintuition Base UnitSPBU2024-11-22
08719992742509Sirius PintuitionSirius Pintuition Bracket Packet 14G x 12cmSPBP122024-11-22

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