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Stainless Steel Guide Wires
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 01-9473-7030Model 01-1007-1701
Identity
- Trade Name
- ORTHOPEDIATRICS® INSTRUMENTATION EUDAMEDStainless Steel Guide Wires FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- ORTHOPEDIATRICS® INSTRUMENTATION EUDAMED2.8mm x 300mm SS Guide Wire, Smooth FDA UDI
- Model / Reference
- 01-9473-7030 EUDAMEDFDA UDI01-1007-1701 EUDAMED
- Description
- 2.8mm x 300mm SS Guide Wire, Smooth FDA UDI
Identifiers
- Catalog Number
- 01-9473-7030 FDA UDI
- Primary DI / UDI-DI
- 00840194465687 EUDAMEDFDA UDI
- Basic UDI-DI
- 08411321CIIAGW52 EUDAMED
- FDA Product Code
- KIJ FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Category: Orthopaedic guidewire, single-use
Stainless Steel Guide Wires by Orthopediatrics Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, single-use.
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
- Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
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- Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I
- FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I
- Headless Screw System Instruments — Tyber Medical · Class I
- SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM — Orthopediatrics Canada ULC · Class I
- Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 Corp.
Sources (2)
- FDA UDI 69660006-99ac-4e12-94af-2f6218e3508c 34 fields · synced Jul 16, 2026
- EUDAMED aaae83d3-bd7b-4cb1-ab74-420463c7efce 61 fields · synced Jul 16, 2026