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Spreader arm for small adult sternum retractor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1010900
by Coroneo Inc.
Identity
- Trade Name
- Spreader arm for small adult sternum retractor EUDAMEDFDA UDI
- Generic Name
- Rib spreader, reusable FDA UDI
- Device Name
- Spreader arm for small adult sternum retractor EUDAMEDThe device is intended to be used for sternal retraction on adult patients. FDA UDI
- Model / Reference
- 1010900 EUDAMEDFDA UDI
- Description
- The device is intended to be used for sternal retraction on adult patients. FDA UDI
Identifiers
- Catalog Number
- 1010900 FDA UDI
- Primary DI / UDI-DI
- 00817121000341 EUDAMED10817121000294 FDA UDI
- Basic UDI-DI
- B-00817121000341 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L08060299 THORACIC SURGERY SPREADERS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Rib spreader, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Spain 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
Spreader arm for small adult sternum retractor 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-00817121000341 | 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 6ef6c4f0-e17b-4b72-9c97-3868d3fa9faa 61 fields · synced Jul 10, 2026
- FDA UDI 84dc3fd7-5017-47f0-9dc1-d4c970d3cc3c 35 fields · synced May 29, 2026