AccessGUDID - DEVICE: spineEOS rod Template (03700757200797)

GUDID

Device Identifier (DI) Information

Brand Name: spineEOS rod Template
Version or Model: KIT0707
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: /
Company Name: ONEFIT MEDICAL

Primary DI Number: 03700757200797
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: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.

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?
58804	Surgical implant template, single-use	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWT	Template

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a06521db-cc95-4460-8b39-3e943a39a42a
Public Version Date: February 02, 2021
Public Version Number: 4
DI Record Publish Date: February 23, 2017