Identity
- Trade Name
- MIASPAS EUDAMEDFDA UDI
- Generic Name
- Laparoscopic access cannula, reusable FDA UDI
- Device Name
- MIASPAS instrument Ir EUDAMEDMIASPAS TL OBTURATOR D12.5MM/UL75MM FDA UDI
- Model / Reference
- EJ364R EUDAMEDFDA UDI
- Description
- MIASPAS TL OBTURATOR D12.5MM/UL75MM FDA UDI
Identifiers
- Catalog Number
- EJ364R FDA UDI
- Primary DI / UDI-DI
- 04038653265770 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000016562X EUDAMED
- Direct Marketing DI
- 04038653265770 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Laparoscopic access cannula, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
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
Miaspas 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 | 40392390000016562X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED d9f4e43c-9774-45be-8de0-1c5abaceee73 61 fields · synced Jun 18, 2026
- FDA UDI fb98563b-1fc6-4416-a08c-783adedf82ae 36 fields · synced May 30, 2026