AccessGUDID - DEVICE: Bunion Bootie (04518227082007)

GUDID

Device Identifier (DI) Information

Brand Name: Bunion Bootie
Version or Model: XSmallLeft
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SLO LIVING LLC

Primary DI Number: 04518227082007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078436895 *Terms of Use

Device Description: Soft, ultra-thin, flexible orthotic for bunions (hallux valgus). The full coverage toe hood covers the big toe and is secured with a heel strap.

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):	Yes
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?
61907	Hallux valgus metatarsophalangeal orthosis	A prefabricated (non-customized) non-rigid, home-use device intended to be worn on the foot to help prevent and/or reduce hallux valgus deformity, thereby reducing walking pain and bunion formation. It is made of elastic fabric materials and may encompass only the metatarsophalangeal region or extend around the heel for tensioning. This is a single-patient reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILG	Stocking, Elastic

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: aab3de6d-93bd-4a98-a0e6-6dd0a58fcc02
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: August 01, 2020