EXOGEN® Ultrasound Bone Healing System 71034400
GUDID M937710344001
The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
BIOVENTUS LLC
Bone growth ultrasonic stimulator| Primary Device ID | M937710344001 |
| NIH Device Record Key | da815334-5d55-4f2d-8e5d-1e91d76ebe17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXOGEN® Ultrasound Bone Healing System |
| Version Model Number | 71034400 |
| Catalog Number | 71034400 |
| Company DUNS | 078450878 |
| Company Name | BIOVENTUS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M937710344001 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P900009
FDA Product Code
| LOF | Stimulator, Bone Growth, Non-Invasive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-01-12 |
On-Brand Devices [EXOGEN® Ultrasound Bone Healing System]
| M937710346001 | The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to |
| M937710344001 | The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions a |
Trademark Results [EXOGEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXOGEN 88090830 not registered Live/Pending |
Serafini, Andrew 2018-08-23 |
 EXOGEN 87744043 not registered Live/Pending |
World Holdings, Inc. 2018-12-20 |
 EXOGEN 86358766 5137953 Live/Registered |
DOLCETTI, JOSEPH CLEARY 2014-08-06 |
 EXOGEN 85672484 not registered Dead/Abandoned |
Cambrian Innovation Inc. 2012-07-10 |
 EXOGEN 85590078 4278603 Live/Registered |
NetXposure, Inc. 2012-04-05 |
 EXOGEN 85509122 not registered Dead/Abandoned |
Smith & Nephew, Inc. 2012-01-05 |
 EXOGEN 78311968 not registered Dead/Abandoned |
Exogen, Inc. 2003-10-10 |
 EXOGEN 77475721 not registered Dead/Abandoned |
Smith & Nephew, Inc. 2008-05-15 |
 EXOGEN 76270662 2756959 Dead/Cancelled |
NetXposure, Inc. 2001-06-13 |
 EXOGEN 75921554 2508939 Live/Registered |
BIOVENTUS, LLC 2000-02-17 |
 EXOGEN 73378437 not registered Dead/Abandoned |
EXOGEN INTERNATIONAL, INC. 1982-08-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.