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The Simple Locking Intra Medullary System
EUDAMEDFDA UDIClass I (EU MDR)
Ref BLT-BKY100Model BULLET KEY
Identity
- Trade Name
- The Simple Locking Intra Medullary System EUDAMEDSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- BULLET KEY FDA UDI
- Model / Reference
- BULLET KEY EUDAMEDBLT-BKY100 EUDAMEDFDA UDI
- Description
- BULLET KEY FDA UDI
Identifiers
- Catalog Number
- BLT-BKY100 FDA UDI
- Primary DI / UDI-DI
- 07540194011633 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SLM-BKVV EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L098002 ORTHOPAEDIC INSTRUMENTS KEYS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, 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
The Simple Locking Intra Medullary System by Orthopediatrics Canada Ulc — 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 | 7540194SLM-BKVV | 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 e9ace5ec-9382-4a51-9262-896fef691c3f 61 fields · synced Jun 19, 2026
- FDA UDI 4d862d8c-90da-4024-9449-d758ff1dc17b 36 fields · synced May 30, 2026