Identity
- Trade Name
- Orthofix FDA UDI
- Generic Name
- Nerve/vessel retractor FDA UDI
- Device Name
- Palatal Retractor EUDAMEDBAYONET RETRACTOR, 12mm FDA UDI
- Model / Reference
- 42-2106 EUDAMEDFDA UDI
- Description
- BAYONET RETRACTOR, 12mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776149123 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190776RETRACT2N EUDAMED
- Direct Marketing DI
- 00190776149123 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
- GMDN Term
- Nerve/vessel retractor 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: Nerve/vessel retractor
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 fc073c8f-9833-4425-9b9d-2a8c422ac800 34 fields · synced Jun 18, 2026
- EUDAMED 00d23ae4-5840-4687-9517-9cef0503fc0f 61 fields · synced Jun 18, 2026