Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Surgical saw blade, oscillating, single-use FDA UDI
- Device Name
- PS-Tools saw blade SU EUDAMEDDISP.SAW BLADE RAPID ACTION 90/13/0.89MM FDA UDI
- Model / Reference
- GE234SU EUDAMEDFDA UDI
- Description
- DISP.SAW BLADE RAPID ACTION 90/13/0.89MM FDA UDI
Identifiers
- Catalog Number
- GE234SU FDA UDI
- Primary DI / UDI-DI
- 04046963728557 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000267438 EUDAMED
- FDA Product Code
- GFA FDA UDI
- EMDN Code
- Z12130502 ORTHOPAEDIC SURGICAL SAWS EUDAMED
- GMDN Term
- Surgical saw blade, oscillating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aesculap by Aesculap AG — Class IIa — 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 | 403923900000267438 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 8ac8e5d7-2344-448e-9124-1fdc4afdba05 61 fields · synced May 30, 2026
- FDA UDI 95ca4aa4-c214-404c-b314-ee8a31b08064 35 fields · synced May 29, 2026