FDA.reportPublic FDA data

HS AMICA

Primary DI
08058983745366
Brand
HS AMICA
Company
H.S. HOSPITAL SERVICE SPA
Model
RF AMICA-PROBE
Catalog number
RF17350E20V2
Device description
RF AMICA-PROBE 17GX350MM EXP. TIP 20MM
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150112000HS AMICA DEVICES FAMILYH.S Hospital Service S.P.A2015-09-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058983745366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058983745366080589837453668058983745366

GMDN Terms#

Term, Definition table
TermDefinition
Tumour-therapy radio-frequency hyperthermia system applicator, intracorporealA component of a radio-frequency (RF) hyperthermia system designed to be placed in the body to deliver radio-frequency (RF) energy to produce a systemic or local heating effect for the treatment of malignant or benign tumours, or other disease conditions. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of RF energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the probe during operation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length350Millimeter
Needle Gauge17Gauge

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
428898555
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16