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The Simple Locking Intra Medullary System
EUDAMEDFDA UDIClass I (EU MDR)
Ref SLM-IME148Model EMPTY IMPLANT CASE
Identity
- Trade Name
- The Simple Locking Intra Medullary System EUDAMEDSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- EMPTY SLIM IMPLANT CASE Ø4.8mm FDA UDI
- Model / Reference
- EMPTY IMPLANT CASE EUDAMEDSLM-IME148 EUDAMEDFDA UDI
- Description
- EMPTY SLIM IMPLANT CASE Ø4.8mm FDA UDI
Identifiers
- Catalog Number
- SLM-IME148 FDA UDI
- Primary DI / UDI-DI
- 07540194008480 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SLM-EIMC2T EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Surgical instrument/implant rack 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-EIMC2T | 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 c7b6c311-5942-4089-aca3-f15026dc7a9a 61 fields · synced Jun 18, 2026
- FDA UDI f486dd3f-e9e2-48fa-82f9-d7161268bace 36 fields · synced May 30, 2026