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Spreader arm - Neonate sternum retractor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1010835
by Coroneo Inc.
Identity
- Trade Name
- Spreader arm - Neonate sternum retractor EUDAMEDFDA UDI
- Generic Name
- Sternum spreader FDA UDI
- Device Name
- Neonate Crank EUDAMEDCrank-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor). FDA UDI
- Model / Reference
- 1010835 EUDAMEDFDA UDI
- Description
- Crank-side spreader arm for the neonate sternum retractor, within the separable assembly 1100211 (Neonate Pediatric Retractor). FDA UDI
Identifiers
- Catalog Number
- 1010835 FDA UDI
- Primary DI / UDI-DI
- D-1010835UB EUDAMED00817121000532 FDA UDI
- Basic UDI-DI
- B-1010835UB 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Spreader arm - Neonate 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
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-1010835UB | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-1010835UB | 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 085a44a3-19ef-4e7c-a2c6-393a27c1191a 61 fields · synced May 31, 2026
- FDA UDI 61987033-b971-4689-8e05-b2cca1a16f45 35 fields · synced May 30, 2026