Identity
- Trade Name
- Medtronic Reusable Instruments FDA UDI
- Generic Name
- Orthopaedic knife FDA UDI
- Device Name
- CUTTER X0599107 9CM-11CM DPTH X 7 DIA FDA UDI
- Model / Reference
- X0599107 FDA UDI
- Description
- CUTTER X0599107 9CM-11CM DPTH X 7 DIA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00673978815886 FDA UDI
- FDA Product Code
- FZT FDA UDI
- GMDN Term
- Orthopaedic knife FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 knife
Introducing the Medtronic Reusable Instruments, a cutting-edge hand-held manual surgical instrument designed for orthopaedic surgeons to make precise cuts and shape bone during complex procedures. Made from high-grade stainless steel, this reusable device is a staple in many operating rooms worldwide.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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 2c908fc6-b74c-45c0-82d7-eb009b355b17 34 fields · synced Jul 31, 2026