AccessGUDID - DEVICE: EBI OsteoGen™ Implantable Bone Growth Stimulator (00812301020065)

GUDID

Device Identifier (DI) Information

Brand Name: EBI OsteoGen™ Implantable Bone Growth Stimulator
Version or Model: 10-1328M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-1328M
Company Name: EBI, LLC

Primary DI Number: 00812301020065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050410323 *Terms of Use

Device Description: OSTEOGEN-20/ML

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?
35463	Patient-worn bone growth electromagnetic stimulator	A battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOE	Stimulator, Invasive Bone Growth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P790005	032

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f5537a42-87a6-4e82-86e2-cbffc8c224b6
Public Version Date: March 10, 2022
Public Version Number: 4
DI Record Publish Date: September 19, 2014