Identity
- Trade Name
- EXOGEN® Ultrasound Bone Healing System FDA UDI
- Generic Name
- Bone growth ultrasonic stimulator FDA UDI
- Device Name
- Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001. FDA UDI
- Model / Reference
- 71034601 FDA UDI
- Description
- Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001. FDA UDI
Identifiers
- Catalog Number
- 71034601 FDA UDI
- Primary DI / UDI-DI
- M937710346011 FDA UDI
- PMA Number
- P900009 FDA UDI
- FDA Product Code
- LOF FDA UDI
- GMDN Term
- Bone growth ultrasonic stimulator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone growth ultrasonic stimulator
EXOGEN® Ultrasound Bone Healing System by Bioventus Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone growth ultrasonic stimulator.
Cleared under the same submission
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
- Bioventus Llc
Sources (1)
- FDA UDI 0874bc09-a46e-43b0-bdc2-33d599bc1469 37 fields · synced May 31, 2026