AccessGUDID - DEVICE: Surgimap® (00859699006042)

GUDID

Device Identifier (DI) Information

Brand Name: Surgimap®
Version or Model: 2.2.9.X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEMARIS, INC

Primary DI Number: 00859699006042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078361251 *Terms of Use

Device Description: The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.

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):	No
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?
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	Active	false
38473	Patient health record information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141669	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: ec6940c5-170a-4142-a943-1b875850521c
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: August 29, 2016