Identity
- Trade Name
- KYPHON® EXPRESS™ Osteo Introducer® Device FDA UDI
- Generic Name
- Bone access channel kit FDA UDI
- Device Name
- INTRODUCER T34E KYPHON EX OI BEVEL FDA UDI
- Model / Reference
- T34E FDA UDI
- Description
- INTRODUCER T34E KYPHON EX OI BEVEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169323094 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone access channel kit 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Bone access channel kit
KYPHON® EXPRESS™ Osteo Introducer® Device by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 326aa73d-5c8c-49f7-b9f5-4e5a70d4ce4c 34 fields · synced May 30, 2026