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Injection needle
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50-345-23Model Injection needles and trocars
Identity
- Trade Name
- Injection needle EUDAMEDFDA UDI
- Generic Name
- Tissue injection cannula FDA UDI
- Device Name
- Injection needle EUDAMEDcurved, luer-lock wl 24 cm, total length 31 cm FDA UDI
- Model / Reference
- Injection needles and trocars EUDAMED50-345-23 EUDAMEDFDA UDI
- Description
- curved, luer-lock wl 24 cm, total length 31 cm FDA UDI
Identifiers
- Catalog Number
- 50-345-23 FDA UDI
- Primary DI / UDI-DI
- 04250381858813 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250381858813 EUDAMED
- FDA Product Code
- GDM FDA UDI
- EMDN Code
- L030199 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER EUDAMED
- GMDN Term
- Tissue injection cannula FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Injection needle by SPIGGLE & THEIS Medizintechnik GmbH — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250381858813 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SPIGGLE & THEIS Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000006647
Sources (2)
- EUDAMED 904d4038-e280-496f-afe8-524d1e19f0a6 61 fields · synced Jul 15, 2026
- FDA UDI ac01fc33-f27d-49bf-8c75-a56f5f3c2a8a 35 fields · synced May 29, 2026