Cup Instrument System - Instrument Tray (Tray)
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Cup Instrument System - Instrument Tray (Tray) EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Cup Instrument System - Instrument Tray EUDAMEDSurgical instrument tray for Incipio Devices instrumentation - tray component FDA UDI
- Model / Reference
- 50740101 EUDAMED50741193 EUDAMEDFDA UDI
- Description
- Surgical instrument tray for Incipio Devices instrumentation - tray component FDA UDI
Identifiers
- Catalog Number
- 50741193 FDA UDI
- Primary DI / UDI-DI
- 07630055304841 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300553507401INTFU EUDAMED
- Direct Marketing DI
- 07630055304841 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical retraction system, reusable
Cup Instrument System - Instrument Tray (Tray) by Incipio Devices SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300553507401INTFU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Incipio Devices SA
- EUDAMED SRN
- CH-MF-000030518
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED a1d3d3bc-adda-4a39-9440-610730ab8bb1 61 fields · synced Jun 19, 2026
- FDA UDI f5f4d0ff-3f6e-4db1-8eed-88f6c19e523e 34 fields · synced May 29, 2026