Identity
- Trade Name
- Universal clamp EUDAMEDFDA UDI
- Generic Name
- Surgical instrument assist arm system structural component FDA UDI
- Device Name
- Universal clamp EUDAMEDThe device is intended to be used to clamp surgical instruments to the adult thoracic retractors manufactured by CORONEO INC. FDA UDI
- Model / Reference
- 1100347 EUDAMEDFDA UDI
- Description
- The device is intended to be used to clamp surgical instruments to the adult thoracic retractors manufactured by CORONEO INC. FDA UDI
Identifiers
- Catalog Number
- 1100347 FDA UDI
- Primary DI / UDI-DI
- 00817121000389 EUDAMED10817121000287 FDA UDI
- Basic UDI-DI
- B-00817121000389 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L0899 THORACIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument assist arm system structural component FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Universal clamp by Coroneo Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817121000389 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coroneo Inc.
- EUDAMED SRN
- CA-MF-000019141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 5826ff12-729c-4819-ad40-cbe9f09ef802 61 fields · synced Aug 4, 2026
- FDA UDI a6204ff6-4df4-4834-9df4-0ed18669a6d7 35 fields · synced May 29, 2026