FDA.reportPublic FDA data

Lung Marker System

Primary DI
04250195600905
Brand
Lung Marker System
Company
SOMATEX Medical Technologies GmbH
Model
272015
Published
2021-10-28
Public version status
Update
Distribution status
Not 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
04250195604804PackageGS110Not in Commercial Distribution
04250195600905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250195604804042501956048044250195604804
04250195600905042501956009054250195600905

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.

Regulatory Flags#

DUNS number
341679629
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
04250195600806TUMARK2715502715502015-10-27
04250195600813TUMARK Professional2715602715602015-10-30
04250195600820TUMARK Professional2715652715652015-10-30
04250195600837Tuloc2716602021-10-28
04250195600844Tuloc2716612021-10-28
04250195600851Tuloc2716632021-10-28
04250195600899Lung Marker System2720122021-10-28
04250195601605MRI Tuloc6016492021-10-28
04250195601612MRI Tuloc6016512021-10-28
04250195602046Tuloc Premium2718802021-10-28
04250195602053Tuloc Premium2718812021-10-28
04250195602060Tuloc Premium2718832021-10-28
04250195602183TUMARK Flex2715702715702015-11-03
04250195602190TUMARK Flex2715722715722015-11-03
04250195602213TUMARK Flex2715762715762015-11-03
04250195602282TUMARK Professional X-Shape2715492715492015-10-30
04250195602350Tumark MRI6015706015702015-10-30
04250195603005Q-Wire System2714632021-10-28
04250195603029Q-Wire System2714622021-10-28
04250195603036Q-Wire System2714642021-10-28

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
18059174746985MEDWIREMEDAX 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
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