Identity
- Trade Name
- Medtronic Reusable Instruments FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
- Device Name
- PEDICLE MARKER EX0411331 5MM FDA UDI
- Model / Reference
- EX0411331 FDA UDI
- Description
- PEDICLE MARKER EX0411331 5MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994994110 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
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: Abdominal/ENT/orthopaedic surgical probe, reusable
Medtronic's Reusable Instruments are designed for use in abdominal, ENT, and orthopaedic surgical interventions. These hand-held instruments are made of rigid or flexible metallic and/or synthetic polymer material, featuring a slender design with various tip shapes. With their sterilization methods including Moist Heat or Steam Sterilization and a single-use capability, these devices can be reused.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 8e6ac675-43c9-493c-984e-b50f5b9fc194 34 fields · synced Jul 18, 2026