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ACETABULAR REAMER EVO 2 DRAGGER D61 mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref H0037556199Model ACETABULAR REAMER EVO 2 DRAGGER
by Hpf Srl
Identity
- Trade Name
- ACETABULARRIVAL EVO 2 FØRER D61 mm EUDAMEDACETABULAR REAMER EVO 2 DRAGGER D61 mm FDA UDI
- Generic Name
- Burring power tool attachment FDA UDI
- Model / Reference
- H0037556199 EUDAMEDFDA UDIACETABULAR REAMER EVO 2 DRAGGER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057968717312 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08057968717312 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Burring power tool attachment 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Burring power tool attachment
ACETABULAR REAMER EVO 2 DRAGGER D61 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
European Union Unknown
MDD
United States Pending data
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 086866ba-435b-41b6-b2e7-4b6732a65f90 32 fields · synced Jul 23, 2026
- EUDAMED 5c587cd2-8bdf-4e8e-bb4b-78b945727714 61 fields · synced Jul 23, 2026