FDA.reportPublic FDA data

TRAP EASY

Primary DI
38058983745916
Brand
TRAP EASY
Company
H.S. HOSPITAL SERVICE SPA
Model
TRAP EASY
Catalog number
TRAPEASY 1110
Device description
TRAP EASY 11GX100MM
Published
2024-12-20
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
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242029000TRAP EASYH.S Hospital Service S.P.A2024-10-09KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38058983745916PackageGS110In Commercial Distribution
08058983745915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3805898374591638058983745916
08058983745915080589837459158058983745915

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Needle Gauge11Gauge

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
06937278630643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630841CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630858CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630865CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630872CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630889CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630896CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630902CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630919CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630926CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631046CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631053CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631060CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631077CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631084CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631091CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631107CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631114CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631121CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631138CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631145CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08