AccessGUDID - DEVICE: hipEOS (03700757200827)

GUDID

Device Identifier (DI) Information

Brand Name: hipEOS
Version or Model: 2.x
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: /
Company Name: ONEFIT MEDICAL

Primary DI Number: 03700757200827
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 263373588 *Terms of Use

Device Description: hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant.

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?
46470	Orthopaedic/craniofacial implantation planning software	A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the 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 [?]
Premarket Submission Number Not Available/Not Released

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: e87f3232-191c-4360-af7f-736189b7bdfa
Public Version Date: February 02, 2021
Public Version Number: 4
DI Record Publish Date: February 13, 2017