FDA.reportPublic FDA data

PRECISA

Primary DI
28033003345249
Brand
PRECISA
Company
H.S. HOSPITAL SERVICE SPA
Model
PRECISA
Catalog number
PRE 1615
Device description
PRECISA 16GX150MM
Published
2016-12-04
Public version status
Update
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
K002944000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002944000PRECISA BIOPSY NEEDLEH.S. Hospital Service S.R.L.2000-12-19FCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28033003345249PackageGS15In Commercial Distribution
38033003345246PackageGS110In Commercial Distribution
08033003345245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2803300334524928033003345249
3803300334524638033003345246
08033003345245080330033452458033003345245

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
Needle Gauge16Gauge

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
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
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
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
08033860041847BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041854BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041861BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041878BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041885BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041892BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041908BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041915BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041922BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041939BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041946BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041953BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041960BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860001728BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001742BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001766BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860002558BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860017361BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03