Identity
- Trade Name
- Orthofix FDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- LAT 4MM STRAIGHT CURETTE EUDAMEDCURETTE, STRAIGHT, SIZE #1 FDA UDI
- Model / Reference
- 42-2202 EUDAMEDFDA UDI
- Description
- CURETTE, STRAIGHT, SIZE #1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776149291 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190776SCRAPVZ EUDAMED
- Direct Marketing DI
- 00190776149291 EUDAMED
- FDA Product Code
- HTF 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
- Bulgaria 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
Yes
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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone curette, reusable
Orthofix by AVALIGN TECHNOLOGIES, Inc. — 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
- AVALIGN TECHNOLOGIES, Inc.
Sources (2)
- FDA UDI 3847e1cc-caf6-4708-9d1e-5b1a88d29618 34 fields · synced Jun 19, 2026
- EUDAMED 879b1c36-b0ba-4ab6-bd20-9c50d4f8dbf6 61 fields · synced Jun 19, 2026