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The Hinge Pediatric Plating System
EUDAMEDFDA UDIClass I (EU MDR)
Ref HPT112Model TEMPLATE
Identity
- Trade Name
- The Hinge Pediatric Plating System EUDAMEDHINGE PEDIATRIC PLATING SYSTEM FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- HINGE PLATE TEMPLATE 12mm FDA UDI
- Model / Reference
- TEMPLATE EUDAMEDHPT112 EUDAMEDFDA UDI
- Description
- HINGE PLATE TEMPLATE 12mm FDA UDI
Identifiers
- Catalog Number
- HPT112 FDA UDI
- Primary DI / UDI-DI
- 07540194007704 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194HP-TPLTB EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4800 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
Dimensions & Sizes
- Size
- Length — 12 Millimeter 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-TPLTB | 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 9e944123-7b8e-418c-9e0d-415ed1338b77 61 fields · synced Jun 20, 2026
- FDA UDI e45419dc-88c4-4ed4-a7bd-8f5fc1de9024 37 fields · synced May 30, 2026