Simple Locking Intramedullary (slim) System
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- The Simple Locking Intra Medullary System EUDAMEDSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- SLIM REAMER Ø4.0mm FDA UDI
- Model / Reference
- SLM-DCA040 EUDAMEDFDA UDIREAMER EUDAMED
- Description
- SLIM REAMER Ø4.0mm FDA UDI
Identifiers
- Catalog Number
- SLM-DCA040 FDA UDI
- Primary DI / UDI-DI
- 07540194008329 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SLM-RZN EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L1508 REAMERS, REUSABLE EUDAMED
- GMDN Term
- Cannulated surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDILength — 330 Millimeter FDA UDILumen/Inner Diameter — 1.8 Millimeter FDA UDI
Category: Cannulated surgical drill bit, reusable
Simple Locking Intramedullary (slim) System by Orthopediatrics Canada ULC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Cannulated surgical drill bit, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI ae892ddd-ee37-4fb1-bf0a-4c80d58047a7 37 fields · synced Jun 20, 2026
- EUDAMED 2d30f132-de8c-455e-829b-b98a1ba8a914 61 fields · synced Jun 20, 2026