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The Simple Locking Intra Medullary System
EUDAMEDFDA UDIClass I (EU MDR)
Ref PEG-CEM-20Model EMPTY IMPLANT CADDY
Identity
- Trade Name
- The Simple Locking Intra Medullary System EUDAMEDSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- EMPTY 2.0mm PEG CADDY FDA UDI
- Model / Reference
- EMPTY IMPLANT CADDY EUDAMEDPEG-CEM-20 EUDAMEDFDA UDI
- Description
- EMPTY 2.0mm PEG CADDY FDA UDI
Identifiers
- Catalog Number
- PEG-CEM-20 FDA UDI
- Primary DI / UDI-DI
- 07540194012029 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SLM-EPCXZ EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden 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
Category: Instrument tray, reusable
The Simple Locking Intra Medullary System by Orthopediatrics Canada Ulc — 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 | 7540194SLM-EPCXZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED f994ff95-81ad-4e30-956e-46b78a0dcb88 61 fields · synced Jun 19, 2026
- FDA UDI 01e14b6c-1f4d-4166-bb9d-fe013712590b 36 fields · synced May 30, 2026