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Pinion for pediatric retractors
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1010850
by Coroneo Inc.
Identity
- Trade Name
- Pinion for pediatric retractors EUDAMEDFDA UDI
- Generic Name
- Sternum spreader FDA UDI
- Device Name
- Pinion for pediatric retractors EUDAMEDPinion for the pediatric retractors, within separable assemblies 1100210 (Infant Pediatric Retractor) and 1100211 (Neonate Pediatric Retractor). FDA UDI
- Model / Reference
- 1010850 EUDAMEDFDA UDI
- Description
- Pinion for the pediatric retractors, within separable assemblies 1100210 (Infant Pediatric Retractor) and 1100211 (Neonate Pediatric Retractor). FDA UDI
Identifiers
- Catalog Number
- 1010850 FDA UDI
- Primary DI / UDI-DI
- D-1010850U7 EUDAMED00817121000570 FDA UDI
- Basic UDI-DI
- B-1010850U7 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L0804 STERNOTOMY SURGICAL INSTRUMENTS, REUSABLE EUDAMED
- GMDN Term
- Sternum spreader 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Pinion for pediatric retractors 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-1010850U7 | 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 9d52f083-65f6-4335-90c6-263b41c7f9be 61 fields · synced Jul 21, 2026
- FDA UDI 0e9c2eb2-a87a-40b2-9fde-6976e4507a21 35 fields · synced May 30, 2026