FDA.reportPublic FDA data

MEDWIRE

Primary DI
18059174746985
Brand
MEDWIRE
Company
MEDAX SRL UNIPERSONALE
Model
XW20100-1S
Device description
Non-repositionable system for preoperative localization of non palpable breast lesions 20G x 100mm
Published
2022-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MIJNeedle, Tumor Localization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIJNeedle, Tumor LocalizationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18059174746985PackageGS110In Commercial Distribution
08059174746988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805917474698518059174746985
08059174746988080591747469888059174746988

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, external, single-useA device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
440211428
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052283955661COX for MEDONECO18160-102019-10-02
08052283955678COX for MEDONECO20100-102019-10-02
08052283955692MEDONEMO20200-K02019-10-02
08052283955715MED-BXB08100-002020-07-07
08052283955722MED-BXB08150-002020-07-07
08052283955739MED-BXB11100-002020-07-07
08052283955746MED-BXB11150-002020-07-07
08052283955753MED-BXB13070-002020-07-07
08052283955760MED-BXB13100-002020-07-07
08052283955777MED-BXB13150-002020-07-07
08052283955845MED-LXL08100-0S2020-07-07
08052283955852MED-LXL08150-0S2020-07-08
08052283955869MED-LXL11100-0S2020-07-08
08052283955876MED-LXL11150-0S2020-07-08
08052283955883MED-LXL13070-0S2020-07-08
08052283955890MED-LXL13100-0S2020-07-08
08052283955906MED-LXL13150-0S2020-07-08
08052283955913MED-LXL08100-0P2020-07-08
08052283955920MED-LXL08150-0P2020-07-08
08052283955937MED-LXL11100-0P2020-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009883703Mammo-Flex Quad-Flex Localization SystemDfc Medical LLCMIJ2023-10-17
08033003340349ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
48033003340347ALM SETH.S. HOSPITAL SERVICE SPAMIJ2023-04-19
08059174746964MEDWIREMEDAX SRL UNIPERSONALEMIJ2023-01-03
08059174747084MEDWIREMEDAX SRL UNIPERSONALEMIJ2023-01-03
08059174746971MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747008MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747091MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747107MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174747121MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-12-20
08059174746988MEDWIREMEDAX SRL UNIPERSONALEMIJ2022-07-15
04250195600837TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600844TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600851TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600899Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195600905Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195601605MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195601612MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602046Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602053Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195602060Tuloc PremiumSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603005Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603029Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195603036Q-Wire SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604705TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604712TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604729TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604798Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195604804Lung Marker SystemSOMATEX Medical Technologies GmbHMIJ2021-10-28
04250195605825MRI TulocSOMATEX Medical Technologies GmbHMIJ2021-10-28