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ACCESSRAIL Platform (Deep Blade)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DB-1000Model Accessrail Platform Blades
Identity
- Trade Name
- Accessrail Platform Deep Blades EUDAMEDACCESSRAIL Platform (Deep Blade) FDA UDI
- Generic Name
- Sternum spreader FDA UDI
- Device Name
- Accessrail Platform Deep Blades EUDAMEDACCESSRAIL Platform (Deep Blade) FDA UDI
- Model / Reference
- DB-1000 EUDAMEDFDA UDIAccessrail Platform Blades EUDAMED
- Description
- ACCESSRAIL Platform (Deep Blade) FDA UDI
Identifiers
- Catalog Number
- DB-1000 FDA UDI
- Primary DI / UDI-DI
- 00607567700482 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00607567700482 EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- C03900299 BEATING HEART CARDIOSURGERY DEVICES - OTHER EUDAMED
- GMDN Term
- Sternum spreader FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sternum spreader
ACCESSRAIL Platform (Deep Blade) by Maquet Cardiovascular LLC — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Sternum spreader.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maquet Cardiovascular LLC
Sources (2)
- FDA UDI 700dbd19-d9f6-4d01-9227-0ca73e57ad66 35 fields · synced Jul 9, 2026
- EUDAMED cf7faff5-a61e-40fd-ae3a-951830736baf 61 fields · synced Jul 9, 2026