Drill for fixation pin RealGUIDE Z3D Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
by 3diemme Srl
Identity
- Trade Name
- FIXATION PIN EUDAMEDDrill for fixation pin RealGUIDE Z3D Kit FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Surgical instruments for dental implantology - Cutting Tools EUDAMED
- Model / Reference
- STRMTAGL-1, STRMTAGL-2, STRMTAGL-3, STRMTAGL-4, STRMTAGL-5, STRMTAGL-6, STRMTAGL-7 EUDAMED3DMUS00609 EUDAMED3DM00610ZUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050038834100 EUDAMED08050038831185 FDA UDI
- Basic UDI-DI
- 805003883STRMTAGLC3 EUDAMED
- FDA Product Code
- QRQ FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Drill for fixation pin RealGUIDE Z3D Kit by 3diemme Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3diemme Srl
Sources (2)
- FDA UDI ee38afa4-8eb3-4800-a8a8-df61dfa9ec47 32 fields · synced Oct 6, 2026
- EUDAMED 8c142518-648a-4451-be51-d69ec0706ac7 61 fields · synced Jul 9, 2026