AccessGUDID - DEVICE: Formthotics (09419430002996)

GUDID

Device Identifier (DI) Information

Brand Name: Formthotics
Version or Model: FM01-JrSmC-Db-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FOOT SCIENCE INTERNATIONAL LIMITED

Primary DI Number: 09419430002996
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 590255113 *Terms of Use

Device Description: Formthotics Medical Junior - 04

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?
59098	Orthotic insole, prefabricated, antimicrobial	A prefabricated orthopaedic shoe insert typically available for use by a layperson intended to provide supplemental support for the arch and/or heel of the foot, whilst inhibiting microbes such as viruses, bacteria and fungi. It is typically made of fabric and/or synthetic polymer materials (e.g., wool, viscose, silicone gel, foam) impregnated with an antimicrobial substance, which is designed to resist extreme load and may provide thermal insulation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQI	Orthosis, Limb Brace

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: a1f3c30c-78aa-41e4-ab0a-b233e12f23b3
Public Version Date: February 09, 2024
Public Version Number: 1
DI Record Publish Date: February 01, 2024