AccessGUDID - DEVICE: Orthofix Osteogenesis Stimulator (18257200080779)

GUDID

Device Identifier (DI) Information

Brand Name: Orthofix Osteogenesis Stimulator
Version or Model: 3315
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 653315-0017
Company Name: Orthofix US LLC

Primary DI Number: 18257200080779
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 927083808 *Terms of Use

Device Description: Physio-Stim Osteogenesis Stimulator

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
LOF	Stimulator, bone growth, non-invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P850007	032

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 -10 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5decabd6-0364-4c01-a619-287721c5d7b1
Public Version Date: February 16, 2023
Public Version Number: 4
DI Record Publish Date: May 12, 2015