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VELYS Baskets, Trays and Cases
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4515-70-114Ref 4515-70-004Ref 4515-70-006
Identity
- Trade Name
- VELYS EUDAMEDFDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDIInstrument tray, reusable FDA UDI
- Device Name
- VELYS Baskets, Trays and Cases EUDAMEDVELYS Array Drill Pins EUDAMEDVELYS Robot-Assisted Solution ARRAY DRILL PIN 100 mm x 4 mm FDA UDIVELYS Robotic-Assisted Solution SAW HANDPIECE CLEANING BASKET FDA UDIVELYS Robot-Assisted Solution ARRAY DRILL PIN 175 mm x 4 mm FDA UDI
- Model / Reference
- 4515-70-114 EUDAMEDFDA UDI4515-70-004 EUDAMEDFDA UDI4515-70-006 EUDAMEDFDA UDI
- Description
- VELYS Robot-Assisted Solution ARRAY DRILL PIN 100 mm x 4 mm FDA UDIVELYS Robotic-Assisted Solution SAW HANDPIECE CLEANING BASKET FDA UDIVELYS Robot-Assisted Solution ARRAY DRILL PIN 175 mm x 4 mm FDA UDI
Identifiers
- Catalog Number
- 451570004 FDA UDI451570114 FDA UDI451570006 FDA UDI
- Primary DI / UDI-DI
- 10603295519447 EUDAMEDFDA UDI10603295519089 EUDAMEDFDA UDI10603295519102 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0029595 EUDAMED0603295a002899A EUDAMED
- Direct Marketing DI
- 10603295519447 EUDAMED
- FDA Product Code
- LXH FDA UDIFSM FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMEDZ12130485 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use FDA UDIInstrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
VELYS Baskets, Trays and Cases by DePuy Ireland UC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0603295a0029595 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (6)
- EUDAMED 173c7e86-4b8f-44fe-b60d-0ef7c20a0b23 61 fields · synced Jul 16, 2026
- FDA UDI 03d6b8fd-d2db-4eea-a03a-68785bd2f1d8 35 fields · synced May 30, 2026
- FDA UDI 8a5d269e-e797-4dd3-8f1e-60625d842ac4 35 fields · synced May 30, 2026
- FDA UDI ce07dfac-cf94-4a0d-a569-d888154fdb41 35 fields · synced May 30, 2026
- EUDAMED f60fb172-3b79-4e0a-9a52-12e0af3fd2a1 61 fields · synced Jul 10, 2026
- EUDAMED 6df6e2ed-884d-4950-ae4b-f8031b36f15e 61 fields · synced Jul 16, 2026