FDA.reportPublic FDA data

Sirius Pintuition

Primary DI
08719992742509
Brand
Sirius Pintuition
Company
Sirius Medical Systems B.V.
Model
Sirius Pintuition Bracket Packet 14G x 12cm
Catalog number
SPBP12
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
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PBYTemporary Tissue Marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBYTemporary Tissue MarkerGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719992742509PackageGS15In Commercial Distribution
08719992742516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719992742509087199927425098719992742509
08719992742516087199927425168719992742516

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Centimeter

Sterilization Methods#

Method table
Method

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
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
08719992742974Sirius PintuitionSirius Pintuition ProbeSPP2024-11-22
08719992742998Sirius PintuitionSirius Pintuition Base UnitSPBU2024-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719992742516Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742530Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742592Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742882Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742943Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742974Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
08719992742998Sirius PintuitionSirius Medical Systems B.V.PBY2024-11-22
10855436007041LOCalizerHEALTH BEACONS INCPBY2018-05-03
10855436007058LOCalizerHEALTH BEACONS INCPBY2018-05-03
10855436007065LOCalizerHEALTH BEACONS INCPBY2018-05-03
00852205006017SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006024SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006031SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006048SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006093SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
10852205006014SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006055SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006062SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006079SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00852205006086SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
10852205006090SAVI SCOUT®CIANNA MEDICAL, INC.PBY2017-11-22
00855436007013LOCalizerHEALTH BEACONS, INC.PBY2017-06-16
00855436007020LOCalizerHEALTH BEACONS, INC.PBY2017-06-16
10855436007010LOCalizerHEALTH BEACONS INCPBY2017-06-16
10855436007027LOCalizerHEALTH BEACONS INCPBY2017-06-16
00855436007037LOCalizerHEALTH BEACONS, INC.PBY2017-06-16