Identity
- Trade Name
- ORTHOPEDIATRICS® INSTRUMENTATION EUDAMEDLCB FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- ORTHOPEDIATRICS® INSTRUMENTATION EUDAMED2.0mm Wire Guide Stick FDA UDI
- Model / Reference
- 01-1200-8000 EUDAMEDFDA UDI01-1007-0007 EUDAMED
- Description
- 2.0mm Wire Guide Stick FDA UDI
Identifiers
- Catalog Number
- 01-1200-8000 FDA UDI
- Primary DI / UDI-DI
- 00841132137437 EUDAMEDFDA UDI
- Basic UDI-DI
- 08411321CIRINSTCE EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands 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
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Lcb by Orthopediatrics Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 Corp.
Sources (2)
- FDA UDI 99d4d609-d8e5-4f36-a076-5df62a9c274c 35 fields · synced Oct 8, 2026
- EUDAMED 09f8d293-94c4-4dbf-acde-930b50309316 61 fields · synced Oct 8, 2026