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Gangi-HydroGuard 17G, 12.1 cm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HG17-121
by AprioMed AB
Identity
- Trade Name
- Gangi-HydroGuard 17G, 12.1 cm EUDAMEDGangi-HydroGuard Coaxial Needle FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Gangi EUDAMEDGangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 17G x 12.1cm. FDA UDI
- Model / Reference
- HG17-121 EUDAMEDG045 FDA UDI
- Description
- Gangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 17G x 12.1cm. FDA UDI
Identifiers
- Catalog Number
- HG17-121 FDA UDI
- Primary DI / UDI-DI
- 07350031350456 EUDAMEDFDA UDI
- Basic UDI-DI
- 73500313512KJ EUDAMED
- 510(k) Number
- K181756 FDA UDI
- FDA Product Code
- FCG FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 17 Gauge FDA UDILength — 12.1 Centimeter FDA UDI
Gangi-HydroGuard 17G, 12.1 cm by Apriomed AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73500313512KJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- AprioMed AB
- EUDAMED SRN
- SE-MF-000001013
Sources (2)
- EUDAMED bc216d82-cce1-4431-a1e5-2927b7553421 61 fields · synced Jul 11, 2026
- FDA UDI ce4e56a5-602f-4aeb-be62-f484a3fe6fb8 37 fields · synced May 30, 2026