Identity
- Trade Name
- Orthofix FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Case / Tray EUDAMEDALIF Disc Prep Instrument Case 1 FDA UDI
- Model / Reference
- 6378-100-101 EUDAMEDFDA UDI
- Description
- ALIF Disc Prep Instrument Case 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776129514 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190776TRAYSZE EUDAMED
- Direct Marketing DI
- 00190776129514 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Instrument tray, 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
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
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: Instrument tray, reusable
Orthofix by AVALIGN TECHNOLOGIES, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
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 9bcd3947-6c86-409b-bf3b-808e19cb216e 34 fields · synced Jun 19, 2026
- EUDAMED 2b0631e3-4086-4052-b808-6274df8cb148 61 fields · synced Jun 19, 2026