Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- Cervical und lumbar curette EUDAMEDCurette, angled forwards, 8 1/2", (215 mm), working length: 3 1/8", (80 mm), bayonet-shaped, sharp, Fig. 000, non-sterile, reusable FDA UDI
- Model / Reference
- MF258R EUDAMEDFDA UDI
- Description
- Curette, angled forwards, 8 1/2", (215 mm), working length: 3 1/8", (80 mm), bayonet-shaped, sharp, Fig. 000, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- MF258R FDA UDI
- Primary DI / UDI-DI
- 04046963344375 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000000323ZP EUDAMED
- FDA Product Code
- FZS FDA UDI
- EMDN Code
- L1102 NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Bone curette, reusable 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
Category: Surgical retractor/retraction system blade, reusable
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, reusable.
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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 | 4039239000000323ZP | 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 96cb17c7-f227-4f4d-9388-8b939181644a 61 fields · synced May 30, 2026
- FDA UDI f36a1bd3-3f82-4fae-85d1-cb686c58c1e0 35 fields · synced May 30, 2026