Identity
- Trade Name
- INTRODUCER EUDAMEDFDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- INTRODUCER EUDAMEDCHIBA introducer needle, 21Gx20.7 cm FDA UDI
- Model / Reference
- EI AG2 0020 640 EUDAMEDFDA UDI
- Description
- CHIBA introducer needle, 21Gx20.7 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08052286590289 EUDAMED08052286590142 FDA UDI
- Basic UDI-DI
- 805228659EIAG20020xxxLB EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy 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
No
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
Yes
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
- Needle Gauge — 21 Gauge FDA UDILength — 207 Millimeter FDA UDI
Introducer by Elesta Spa — 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 | 805228659EIAG20020xxxLB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ELESTA SpA
- EUDAMED SRN
- IT-MF-000037909
Sources (2)
- EUDAMED f91eab99-3f37-4e09-982c-aa8363fee655 61 fields · synced Jul 17, 2026
- FDA UDI bf7fe62d-1fe4-42ea-9b47-a309d74ac25c 34 fields · synced May 30, 2026