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
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- PEG DRILL 2.4 mm FDA UDI
- Model / Reference
- PEG-PGD124 EUDAMEDFDA UDIPEG DRILL EUDAMED
- Description
- PEG DRILL 2.4 mm FDA UDI
Identifiers
- Catalog Number
- PEG-PGD124 FDA UDI
- Primary DI / UDI-DI
- 07540194011763 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194SLM-PDWR EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
- GMDN Term
- Fluted 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
- Length — 150 Millimeter FDA UDIOuter Diameter — 2.35 Millimeter FDA UDI
Category: Fluted 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
Similar devices
Also classified as Fluted surgical drill bit, reusable.
- RingLoc® + — Biomet Orthopedics, Inc. · Class I
- DLC Cortical Bone Drill 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class II
- MatrixMANDIBLE — Synthes · Class II
- Brasseler — SUNCOAST DENTAL, INC. · Class I
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 22ef02b7-cd9b-4fde-b566-d3e75b9b24df 37 fields · synced Jun 11, 2026
- EUDAMED 480e3efe-af4c-4534-8bdc-dd3bd582128f 61 fields · synced Jun 11, 2026