Identity
- Trade Name
- Surgical Instruments EUDAMEDSurgical Instrument FDA UDI
- Generic Name
- Bone fixation plate pliers FDA UDI
- Device Name
- Cutter EUDAMED
- Model / Reference
- 111-042 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809265159902 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000894097615F EUDAMED
- FDA Product Code
- HXZ FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone fixation plate pliers FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutting forceps, reusable
Surgical Instruments by Jeil Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 88000894097615F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jeil Medical Corporation
- EUDAMED SRN
- KR-MF-000008788
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4ff6b491-e0a3-4816-953c-0694f2f64aa5 61 fields · synced Jun 20, 2026
- FDA UDI 2416c7cd-7488-4aa2-aec9-760b9613a48b 32 fields · synced May 30, 2026