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Suprapatellar Protection Sleeve Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1117Model INS-1109
by OrthoXel DAC
Identity
- Trade Name
- Suprapatellar Protection Sleeve Handle EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- Suprapatellar Protection Sleeve Handle EUDAMEDFDA UDITibial Infrapatellar Insertion Handle EUDAMED
- Model / Reference
- INS-1117 EUDAMEDFDA UDIINS-1109 EUDAMED
- Description
- Suprapatellar Protection Sleeve Handle FDA UDI
Identifiers
- Catalog Number
- INS-1117 FDA UDI
- Primary DI / UDI-DI
- 05391529584146 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529584146 EUDAMED53915295840616F EUDAMED
- Direct Marketing DI
- 05391529584146 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic instrument surgical connector 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
Suprapatellar Protection Sleeve Handle by OrthoXel DAC — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05391529584146 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529584146 | 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 7eeb0a89-a67e-4e2d-8277-4238e7d9231e 61 fields · synced Jul 30, 2026
- EUDAMED 94b0ccce-b44a-476f-9b57-b9a1cd4f2554 61 fields · synced May 19, 2026
- FDA UDI 04919df5-d43a-44d3-a603-67ab214f24c3 36 fields · synced May 30, 2026