Identity
- Trade Name
- PRESTIGE LP™ FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- PUNCH 6972425 RAIL FDA UDI
- Model / Reference
- 6972425 FDA UDI
- Description
- PUNCH 6972425 RAIL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994490735 FDA UDI
- PMA Number
- P090029 FDA UDI
- FDA Product Code
- MJO FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class III 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
No
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
Dimensions & Sizes
- Size
- Depth — 12.0 Millimeter FDA UDIHeight — 5.0 Millimeter FDA UDI
Category: Bone-resection orthopaedic reamer, reusable
Prestige Lp™ by Medtronic Sofamor Danek, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-resection orthopaedic reamer, reusable.
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- LINK Instruments - Drills, reamers and saw blades — WALDEMAR LINK GmbH & Co. KG · Class I
Cleared under the same submission
P090029 also covers:
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 723e9880-1ed4-49df-9a6c-47b19c5e52e3 36 fields · synced Jun 1, 2026