AccessGUDID - DEVICE: OrthoGrid Hip Trauma (00860003424827)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoGrid Hip Trauma
Version or Model: 2010-915-502
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orthogrid Systems, Inc.

Primary DI Number: 00860003424827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079674160 *Terms of Use

Device Description: OrthoGrid Trauma for non-invasive software system that provides image analysis tools for trauma procedures

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:	No
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?
64050	Orthopaedic fluoroscopic grid software	A software program intended for use during an orthopaedic surgical procedure to enhance fluoroscopic images with a visual tool in the form of an overlaid grid, whereby the grid is intended to highlight fluoroscopic distortion and e.g., assist placement of an implant.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192279	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1e28b5d-5440-4123-9606-852d8e1cb650
Public Version Date: September 06, 2021
Public Version Number: 1
DI Record Publish Date: August 27, 2021