FDA.reportPublic FDA data

ALM SET

Primary DI
48033003340347
Brand
ALM SET
Company
H.S. HOSPITAL SERVICE SPA
Model
ALM SET Z TYPE
Catalog number
ALMZ 2010
Device description
ALM SET 20GX100MM
Published
2023-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
48033003340347PackageGS120In Commercial Distribution
08033003340349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4803300334034748033003340347
08033003340349080330033403498033003340349

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization 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 formed as a wire, needle, bead, clip, stent-like tube or washer, 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
Length100Millimeter
Needle Gauge20Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39069201961hs@hshospitalservice.com

Regulatory Flags#

DUNS number
428898555
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
false
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
08058983746639TRAP EASYTRAP EASYTRAPEASY 08152025-09-23
08033003340806BIOMOLBIOMOLBM 21102025-07-07
08033055140300BIOMOLBIOMOLBM 21152025-07-07
08033003345016PEIT NEEDLEPEIT NEEDLEPEIT21082025-06-12
08033003345054PEIT NEEDLEPEIT NEEDLEPEIT21202025-06-12
08033003345061PEIT NEEDLEPEIT NEEDLEPEIT2120-62025-06-12
08058983746714PEIT NEEDLEPEIT NEEDLEPEIT2108-62025-06-12
08058983746462HS AMICAAMICA-PROBEAPK16200T19V62025-02-14
08058983746479HS AMICAAMICA-PROBEAPK14270T19V562025-02-14
08058983746486HS AMICAAMICA-PROBEAPK14200T19V62025-02-14
08058983746301HS AMICAAMICA-PROBEAPK14400T19V62025-01-28
08033003344682MB SETMB SETMB 22072025-01-09
48033003344680MB SETMB SETMB 22072025-01-09
08033003347683TOP CUTTOP CUT MTOP 1820M2025-01-09
08033055146081INTRODUCER NEEDLEINTRODUCER NEEDLEIN 16100N MW2025-01-09
08033055146951HS NOTAHS NOTAHS NOTA161502025-01-09
08033055147217HS AMICAAMICA-PROBEAPK16270T19V52025-01-09
08033055148054HS AMICAAMICA-PROBEAPK14150T19V5-DC2025-01-09
08033055149174HS AMICAAMICA-PROBEAPK16150T19V5-DC2025-01-09
08033055149181HS AMICAAMICA-PROBEAPK16200T19V5-DC2025-01-09

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
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
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