FDA.reportPublic FDA data

HS NOTA

Primary DI
38058983744780
Brand
HS NOTA
Company
H.S. HOSPITAL SERVICE SPA
Model
HS NOTA
Catalog number
HS NOTA14100-IN
Device description
HS NOTA 14GX100MM WITH COAXIAL INTRODUCER
Published
2021-03-01
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
FCGBiopsy Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131925000HS NOTAH.S. Hospital Services S.P.A.2014-10-10FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38058983744780PackageGS110In Commercial Distribution
08058983744789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3805898374478038058983744780
08058983744789080589837447898058983744789

GMDN Terms#

Term, Definition table
TermDefinition
Side-notch biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Length100Millimeter
Needle Gauge14Gauge

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
false
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
08033003340073ALM SETALM SET V TYPEALM 200752021-10-04
08033003340127ALM SETALM SET V TYPEALM 20152019-12-18
08033003340172ALM SETALM SET V TYPEALM 21102019-12-18
08033003340240ALM SETALM SET S TYPEALMS 20102016-12-04
08033003340349ALM SETALM SET Z TYPEALMZ 20102023-04-19
08033055143134ALM SETALM SET V TYPEALM 20102019-12-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521833043SharkCoreCovidien LPFCG2026-09-06
10884521833050SharkCoreCovidien LPFCG2026-09-06
10884521833067SharkCoreCovidien LPFCG2026-09-06
10884521833074SharkCoreCovidien LPFCG2026-09-06
10884521833081SharkCoreCovidien LPFCG2026-09-06
10884521833012BeaconCovidien LPFCG2026-09-05
10884521833029BeaconCovidien LPFCG2026-09-05
10884521833036BeaconCovidien LPFCG2026-09-05
10884521833142BeaconCovidien LPFCG2026-09-05
10884521833159BeaconCovidien LPFCG2026-09-05
10884521833166BeaconCovidien LPFCG2026-09-05
04048223088388ChibaSonoPajunk GmbH MedizintechnologieFCG2026-06-10
08800025901588BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901601BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901854BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceOLYMPUS MEDICAL SYSTEMS CORP.FCG2025-12-02
04953170409974Single Use Aspiration Needle NA-U401SXOLYMPUS MEDICAL SYSTEMS CORP.FCG2024-07-03
04953170409981Single Use Aspiration Needle NA-U401SXOLYMPUS MEDICAL SYSTEMS CORP.FCG2024-07-03
04953170409998Single Use Aspiration Needle NA-U401SXOLYMPUS MEDICAL SYSTEMS CORP.FCG2024-07-03
08033860002398BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002633BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860019976BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860027179BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043421BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043438BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002572BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860016272BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860027810BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04