Identity
- Trade Name
- MIASPAS EUDAMEDFDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- MIASPAS instrument Ir EUDAMEDMIASPAS Dissector, (310 mm), (80 mm), diam. 9 mm, straight, width: 4,500 mm, non-sterile, reusable FDA UDI
- Model / Reference
- FF335R EUDAMEDFDA UDI
- Description
- MIASPAS Dissector, (310 mm), (80 mm), diam. 9 mm, straight, width: 4,500 mm, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- FF335R FDA UDI
- Primary DI / UDI-DI
- 04038653163557 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000016562X EUDAMED
- Direct Marketing DI
- 04038653163557 EUDAMED
- FDA Product Code
- GDI FDA UDI
- EMDN Code
- L1102 NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery dissector 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
Miaspas 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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- Medfix — Medfix International, LLC · Class I
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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 | 40392390000016562X | 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 3f15306b-a5aa-426b-9da5-4c4f13cdd802 61 fields · synced Jun 18, 2026
- FDA UDI ca700e7d-78f0-42e8-91b2-553fe8bfe2df 35 fields · synced May 30, 2026