AccessGUDID - DEVICE: EXOGEN® Ultrasound Bone Healing System (M937710346011)

GUDID

Device Identifier (DI) Information

Brand Name: EXOGEN® Ultrasound Bone Healing System
Version or Model: 71034601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71034601
Company Name: BIOVENTUS LLC

Primary DI Number: M937710346011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078450878 *Terms of Use

Device Description: Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOF	Stimulator, Bone Growth, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P900009	022

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0874bc09-a46e-43b0-bdc2-33d599bc1469
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 12, 2017