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The Hinge Pediatric Plating System
EUDAMEDFDA UDIClass I (EU MDR)
Ref HP-DGS210Model DUAL GUIDE
Identity
- Trade Name
- The Hinge Pediatric Plating System EUDAMEDHINGE PEDIATRIC PLATING SYSTEM FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- HINGE PLATE DUAL GUIDE -GEN2 FDA UDI
- Model / Reference
- DUAL GUIDE EUDAMEDHP-DGS210 EUDAMEDFDA UDI
- Description
- HINGE PLATE DUAL GUIDE -GEN2 FDA UDI
Identifiers
- Catalog Number
- HP-DGS210 FDA UDI
- Primary DI / UDI-DI
- 07540194015105 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194HP-PDGR9 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, 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 Hinge Pediatric Plating 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 | 7540194HP-PDGR9 | 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 44ed07aa-fe26-4ad8-bc2e-314e0c764dd5 61 fields · synced Jun 17, 2026
- FDA UDI 2d15669b-f1ec-48e8-b1c8-c282c8ed7290 35 fields · synced May 30, 2026