FDA UDI
In Commercial Distribution
🇺🇸 United States
EXOGEN® Ultrasound Bone Healing System MOU
DI: M937710344011
·
Model: 71034401
·
BIOVENTUS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EXOGEN® Ultrasound Bone Healing System MOU
- Primary DI
- M937710344011
- Version / Model
- 71034401
- Catalog Number
- 71034401
- Company Name
- BIOVENTUS LLC
- Labeler DUNS
- 078450878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-12
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c32c3c99-885e-4af1-9077-6877db82b573
Device Description
Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LOF | Stimulator, Bone Growth, Non-Invasive | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18154 | Bone growth ultrasonic stimulator | A mains electricity (AC-powered) device designed to accelerate bone formation (osteogenesis) through the application of ultrasound energy. It typically consists of a pulsed low-intensity ultrasound generator that includes a transducer probe and a retaining and alignment fixture for the probe. The device is typically used to promote healing of nonunion fractures; it is also used to speed the healing of fresh fractures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M937710344011 | HIBCC |
Customer Contacts
- Phone
- 1-800-836-4080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P900009 | 035 |