FLEX. MANDREL COATED D8, 5 mm
FDA UDIEUDAMEDClass I (US FDA UDI)
by Hpf Srl
Identity
- Trade Name
- FLEKS. DORN BELAGT D8,5 mm EUDAMEDFLEX. MANDREL COATED D8,5 mm FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Model / Reference
- H0010450099 EUDAMEDFDA UDIFlexible mandrel (silicone) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968711303 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968711303 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L098001 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY MANDRELS, REUSABLE EUDAMED
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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: Drilling power tool attachment, basic
FLEX. MANDREL COATED D8, 5 mm by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hpf Srl
Sources (2)
- FDA UDI 2aba76c8-8f30-4fde-8c13-f609bf4599ff 32 fields · synced Jul 26, 2026
- EUDAMED 22896311-88ac-41cf-b7ee-6bc85e39ed7d 61 fields · synced Jul 26, 2026