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Long Reamer Case
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1197Model INS-1079
by OrthoXel DAC
Identity
- Trade Name
- Long Reamer Case EUDAMEDApex FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Apex Nailing System Opening and Reaming Case EUDAMEDLong Reamer Case EUDAMEDFDA UDI
- Model / Reference
- INS-1079 EUDAMEDINS-1197 EUDAMEDFDA UDI
- Description
- Long Reamer Case FDA UDI
Identifiers
- Catalog Number
- INS-1197 FDA UDI
- Primary DI / UDI-DI
- 05391529588786 EUDAMEDFDA UDI
- Basic UDI-DI
- 53915295822035V EUDAMEDB-05391529588786 EUDAMED
- Direct Marketing DI
- 05391529588786 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland 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
Long Reamer Case by OrthoXel DAC — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 53915295822035V | Class I | Active |
| EUDAMED | European Union | CE/MDR | 53915295822035V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (3)
- EUDAMED 41111534-b7f3-48f5-bc71-6d1380b4a72f 61 fields · synced Jul 10, 2026
- EUDAMED d5808cc1-ef95-4439-919d-3fa09b9015e2 61 fields · synced May 19, 2026
- FDA UDI c30e424c-86f5-4a3f-b5b7-6d4c41f9c2c3 36 fields · synced May 30, 2026