Identity
- Trade Name
- Aesculap EUDAMEDSQ.LINE FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Chisel / osteotome EUDAMEDLAMBOTTE OSTEOTOME STR 15MM 300MM FDA UDI
- Model / Reference
- FL804R EUDAMEDFDA UDI
- Description
- LAMBOTTE OSTEOTOME STR 15MM 300MM FDA UDI
Identifiers
- Catalog Number
- FL804R FDA UDI
- Primary DI / UDI-DI
- 04046955145775 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000044325 EUDAMED
- Direct Marketing DI
- 04046955145775 EUDAMED
- FDA Product Code
- GFI FDA UDI
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 403923900000044325 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED bc84e89f-f1c1-4b57-9551-f61632b57d72 61 fields · synced May 31, 2026
- FDA UDI e7461961-cd75-46d8-bfe5-03accaba6040 35 fields · synced May 29, 2026