Identity
- Trade Name
- ULTRA-DRIVE TOOL FDA UDI
- Generic Name
- Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- 3 DEGREE 180 MM MALE/FEMALE FDA UDI
- Model / Reference
- 423826 FDA UDI
- Description
- 3 DEGREE 180 MM MALE/FEMALE FDA UDI
Identifiers
- Catalog Number
- 423826 FDA UDI
- Primary DI / UDI-DI
- 00880304372870 FDA UDI
- 510(k) Number
- K031280 FDA UDI
- FDA Product Code
- JXE FDA UDI
- GMDN Term
- Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1550 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hard-tissue ultrasonic surgical system handpiece tip
Ultra-Drive Tool by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K031280 also covers:
- ULTRA DRIVE III CONSOLE — Biomet Orthopedics, Inc.
- ULTRA DRIVE III FOOTSWITCH — Biomet Orthopedics, Inc.
- ULTRA DRIVE III HANDPIECE — Biomet Orthopedics, Inc.
- ULTRA DRIVE III SET — Biomet Orthopedics, Inc.
- ULTRA DRIVE IRRIGATION — Biomet Orthopedics, Inc.
- ULTRA-DRIVE — Biomet Orthopedics, Inc.
- ULTRA-DRIVE III IRRIGATION CLIP — Biomet Orthopedics, Inc.
- ULTRA-DRIVE TOOL — Biomet Orthopedics, Inc.
- ULTRA-DRIVE TOOL — Biomet Orthopedics, Inc.
- ULTRA-DRIVE TOOL — Biomet Orthopedics, Inc.
- ULTRA-DRIVE TOOL — Biomet Orthopedics, Inc.
- ULTRA-DRIVE TOOL — Biomet Orthopedics, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI a10daa0d-89d6-4421-a3ff-3b6b4663eb1a 36 fields · synced May 30, 2026