OSSEOUS Stapes Prosthesis Crimping Forceps
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Osseous EUDAMEDOSSEOUS Stapes Prosthesis Crimping Forceps FDA UDI
- Generic Name
- Dressing/utility forceps, scissors-like, reusable FDA UDI
- Device Name
- Stapes Prosthesis Crimping Forceps EUDAMEDIt is used to crimping of stapes piston loop after proper placement of stapes piston on long process of incus. FDA UDI
- Model / Reference
- EI04 EUDAMEDFDA UDIENT Instruments EUDAMED
- Description
- It is used to crimping of stapes piston loop after proper placement of stapes piston on long process of incus. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08906039316032 EUDAMEDFDA UDI
- Basic UDI-DI
- 89044287FORCVS EUDAMED
- FDA Product Code
- KAE FDA UDI
- EMDN Code
- L140502 EAR SURGERY PLIERS, REUSABLE EUDAMED
- GMDN Term
- Dressing/utility forceps, scissors-like, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dressing/utility forceps, scissors-like, reusable
OSSEOUS Stapes Prosthesis Crimping Forceps by Eon Meditech Private Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Dressing/utility forceps, scissors-like, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Eon Meditech Private Limited
Sources (2)
- FDA UDI 956e1e66-e534-45cf-9999-9a5c1ab2e9f6 34 fields · synced Jun 18, 2026
- EUDAMED 06993998-8572-4e95-b209-8dd8ddbd82c8 61 fields · synced Jun 18, 2026