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Baskets for robotic systems with removable lid – 690x90x100 mm for 1 scope - Single-site
EUDAMEDFDA UDIClass I (EU MDR)
Ref 124.310
Identity
- Trade Name
- Baskets for robotic systems with removable lid – 690x90x100 mm for 1 scope (Xi/Si Endowrist/Single-site) EUDAMEDBasket for robotic systems – 690x90x100 mm for 1 scope (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
- 124.310 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 124.310 FDA UDI
- Primary DI / UDI-DI
- 07899524533179 EUDAMEDFDA UDI
- Basic UDI-DI
- 78995245PBRS6X EUDAMED
- Direct Marketing DI
- 07899524533179 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
- Single-site EUDAMEDFDA UDI
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 – 690x90x100 mm for 1 scope - Single-site by Fábrica de Artefatos Metalúrgicos Itá Ltda. — Class I — MDR, FDA…
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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 ddfc22f1-c43b-492c-a35d-7e0a651e41f5 61 fields · synced Jul 12, 2026
- FDA UDI 46b528e9-d417-44ff-b9b3-b5b768174f45 35 fields · synced May 30, 2026