Hinge Pediatric Plating System
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- The Hinge Pediatric Plating System EUDAMEDHINGE PEDIATRIC PLATING SYSTEM FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- HINGE PLATE DRILL 3.0MM EUDAMEDHINGE PLATE DRILL 3.0 MM -GEN2 FDA UDI
- Model / Reference
- HP-DRL230 EUDAMEDFDA UDIDRILL EUDAMED
- Description
- HINGE PLATE DRILL 3.0 MM -GEN2 FDA UDI
Identifiers
- Catalog Number
- HP-DRL230 FDA UDI
- Primary DI / UDI-DI
- 07540194015112 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194HP-DRTY EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS 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 — 3 Millimeter FDA UDI
Category: Cannulated surgical drill bit, reusable
Hinge Pediatric Plating System by Orthopediatrics Canada ULC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
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 b2f3d66b-99e2-4201-b858-63ea3d3bd820 36 fields · synced Jun 19, 2026
- EUDAMED a89bb921-2b42-4b93-bea8-f307e8bfdc4f 61 fields · synced Jun 19, 2026