Identity
- Trade Name
- Medfix EUDAMEDFDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- Medfix® Lumbar Curette Size 4, 13 3/4" (349mm) Angled, Black Aluminum Handle FDA UDIMedfix® Lumbar Curette Size 2, 13 3/4" (349mm) Straight, Blue Aluminum Handle FDA UDI
- Model / Reference
- MF-9007 EUDAMEDFDA UDICurette EUDAMEDMF-9021 FDA UDI
- Description
- Medfix® Lumbar Curette Size 4, 13 3/4" (349mm) Angled, Black Aluminum Handle FDA UDIMedfix® Lumbar Curette Size 2, 13 3/4" (349mm) Straight, Blue Aluminum Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810021838359 EUDAMEDFDA UDI00810021838496 FDA UDI
- Basic UDI-DI
- 081002183CURETTESL6 EUDAMED
- Direct Marketing DI
- 00810021838359 EUDAMED
- FDA Product Code
- FZS FDA UDI
- EMDN Code
- L0901 ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE EUDAMED
- GMDN Term
- Bone curette, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone curette, reusable
Medfix by Medfix International, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Medfix International, LLC
Sources (3)
- FDA UDI 7d0f4774-472a-4984-ae1a-87d77a5fb2d2 34 fields · synced Oct 6, 2026
- FDA UDI 04739043-5e5c-4fca-9c6a-cd8c2c06ea8e 34 fields · synced May 24, 2026
- EUDAMED 6624ec44-52db-4bb9-8be1-4b3e3fd79742 61 fields · synced Sep 30, 2026