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Neo Delta Self Safe T 16G 50mm
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 3769522Model Safety Peripheral IV catheters
Identity
- Trade Name
- Neo Delta Self Safe T 16G 50mm EUDAMEDNeo Delta Self Safe® FDA UDI
- Generic Name
- Peripheral vascular catheter FDA UDI
- Device Name
- Neo Delta Self Safe T FDA UDI
- Model / Reference
- Safety Peripheral IV catheters EUDAMED3769522 EUDAMEDFDA UDI
- Description
- Neo Delta Self Safe T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08032248000636 EUDAMED08032248376953 FDA UDI
- Basic UDI-DI
- 8032248000026F EUDAMED
- Direct Marketing DI
- 08032248000636 EUDAMED
- FDA Product Code
- FOZ FDA UDI
- EMDN Code
- C0101010202 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, W/O INJECTION VALVES EUDAMED
- GMDN Term
- Peripheral vascular catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Market of Registration
- Spain 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
Dimensions & Sizes
- Size
- Outer Diameter — 1.75 Millimeter FDA UDILength — 50 Millimeter FDA UDI
Neo Delta Self Safe T 16G 50mm by Delta Med Spa — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121007 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8032248000026F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (3)
- EUDAMED 62adf4c1-1b23-40e0-8296-2018a1373da3 61 fields · synced Jul 12, 2026
- FDA UDI 1cf0ce74-391f-463e-81c1-ace62f21b3d0 34 fields · synced May 30, 2026
- FDA 510(k) K121007 1 fields · synced May 18, 2026