AccessGUDID - DEVICE: MatScan VersaTek (B970MV1RES0)

GUDID

Device Identifier (DI) Information

Brand Name: MatScan VersaTek
Version or Model: MatScan VersaTek Platform with FootMat Software for Researchers
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MV1-RES
Company Name: Tekscan, Inc.

Primary DI Number: B970MV1RES0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 178180246 *Terms of Use

Device Description: Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Researchers CD with MatScan 3150 Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session

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?
43829	Body-surface pressure mapping system	An assembly of electronic devices intended to be used to measure the contact pressure between the body surface and a pressure-sensing pad to provide a map of compression forces during planning of/preparation for personal mobility device use or body support device use by a patient. Described as pressure mapping technology (PMT), it includes a sensor pad and a dedicated computer/software for data analysis, and is typically used to customize the shape of a wheelchair seating cushion to reduce the risk of pressure sore development.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFC	System, Pressure Measurement, Intermittent

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: 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: d0c17de1-4bce-4989-a7f4-c43817bc3d5d
Public Version Date: November 19, 2020
Public Version Number: 2
DI Record Publish Date: November 03, 2020