← Back to catalogue
Gangi-SoftGuard 17G, 7.1 cm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SG17-071
by AprioMed AB
Identity
- Trade Name
- Gangi-SoftGuard 17G, 7.1 cm EUDAMEDGangi-SoftGuard Coaxial Needle FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Gangi EUDAMEDGangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 7.1 cm. FDA UDI
- Model / Reference
- SG17-071 EUDAMEDG040 FDA UDI
- Description
- Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 7.1 cm. FDA UDI
Identifiers
- Catalog Number
- SG17-071 FDA UDI
- Primary DI / UDI-DI
- 07350031350401 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
- Length — 7.1 Centimeter FDA UDINeedle Gauge — 17 Gauge FDA UDI
Gangi-SoftGuard 17G, 7.1 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AprioMed AB
- EUDAMED SRN
- SE-MF-000001013
Sources (2)
- EUDAMED c724a4f3-f667-49b3-b52b-4ab4a2253995 61 fields · synced Sep 18, 2026
- FDA UDI 8b315fcb-afa2-43c7-9dfb-40840abbbd84 37 fields · synced May 30, 2026