Identity
- Trade Name
- A.L.P.S. mvX™ FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrumentation EUDAMEDANKLE DISTAL FIB PLT TRAY LID FDA UDI
- Model / Reference
- 770102010 EUDAMEDFDA UDI
- Description
- ANKLE DISTAL FIB PLT TRAY LID FDA UDI
Identifiers
- Catalog Number
- 770102010 FDA UDI
- Primary DI / UDI-DI
- 00196449016693 EUDAMEDFDA UDI
- Basic UDI-DI
- 081001136002WB EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Category: Instrument tray, reusable
A.L.P.S. mvX™ by Tyber Medical — 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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- 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
- Tyber Medical
Sources (2)
- FDA UDI cfd0a6dd-fb96-42b4-b4d0-e0634dd31705 35 fields · synced Jun 18, 2026
- EUDAMED bc50aab3-24a6-4991-ad79-e79ce451dd9f 61 fields · synced Jun 18, 2026