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Gangi-SoftGuard 13G, 17.1 cm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SG13-171
by AprioMed AB
Identity
- Trade Name
- Gangi-SoftGuard 13G, 17.1 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, 13G x 17.1 cm. FDA UDI
- Model / Reference
- SG13-171 EUDAMEDG036 FDA UDI
- Description
- Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 17.1 cm. FDA UDI
Identifiers
- Catalog Number
- SG13-171 FDA UDI
- Primary DI / UDI-DI
- 07350031350364 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 — 17.1 Centimeter FDA UDINeedle Gauge — 13 Gauge FDA UDI
Gangi-SoftGuard 13G, 17.1 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 acef6513-b3df-408c-831d-e5323705c5d7 61 fields · synced Jul 15, 2026
- FDA UDI a6408c76-e5e1-4a94-9ff4-7bf652d2a944 37 fields · synced May 30, 2026