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Baskets for robotic systems with removable lid – 690x260x100 mm for 6 scopes (X…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 124.330
Identity
- Trade Name
- Baskets for robotic systems with removable lid – 690x260x100 mm for 6 scopes (Xi/Si Endowrist/Single-site) EUDAMEDBasket for robotic system – 690x260x100 mm for 6 scopes (Xi/Si Endowrist/S-Site) FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- FAMI Processing Basket for the Versius Ultrasonic Dissector Transducer EUDAMED
- Model / Reference
- 124.330 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 124.330 FDA UDI
- Primary DI / UDI-DI
- 07899524533193 EUDAMEDFDA UDI
- Basic UDI-DI
- 78995245PBRS6X EUDAMED
- Direct Marketing DI
- 07899524533193 EUDAMED
- FDA Product Code
- LRP FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
- Models / Variants
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Northern Ireland 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
No
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
Baskets for robotic systems with removable lid – 690x260x100 mm for 6 scopes (X… by Fábrica de Artefatos Metalúrgicos Itá Ltda. — Class I — MDR, FDA UDI…
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 78995245PBRS6X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fábrica de Artefatos Metalúrgicos Itá Ltda.
- EUDAMED SRN
- BR-MF-000039534
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (2)
- EUDAMED 3589c18d-81d1-45f6-a51b-17af0bc069e4 61 fields · synced Jul 14, 2026
- FDA UDI 35ae33a3-0c99-4150-9569-e6c146246955 35 fields · synced May 30, 2026