Identity
- Trade Name
- S4® EUDAMEDAESCULAP FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- S4_S4E implant. instrument IIa EUDAMEDS4 SCREW DRIVER F/CANUL.POLYAXIAL SCREWS FDA UDI
- Model / Reference
- FW270R EUDAMEDFDA UDI
- Description
- S4 SCREW DRIVER F/CANUL.POLYAXIAL SCREWS FDA UDI
Identifiers
- Catalog Number
- FW270R FDA UDI
- Primary DI / UDI-DI
- 04046963320324 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000017783E EUDAMED
- Direct Marketing DI
- 04046963320324 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Aesculap by Aesculap, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (2)
- FDA UDI 7f9a2448-9946-40c5-ac8d-11ec71b0b706 35 fields · synced Oct 10, 2026
- EUDAMED c60154f6-9896-4aab-977e-6b1fa5d0fb88 61 fields · synced Oct 10, 2026