FDA.reportPublic FDA data

Bunion Bootie

Primary DI
04518227081925
Brand
Bunion Bootie
Company
SLO LIVING LLC
Model
LargeRight
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.
Published
2020-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILGStocking, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILGStocking, ElasticPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04518227081925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04518227081925045182270819254518227081925

GMDN Terms#

Term, Definition table
TermDefinition
Hallux valgus metatarsophalangeal orthosisA non-rigid 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. It is normally available [non-prescription] over-the-counter (OTC) for use in the home. This is a single-patient use device that can be reapplied by the patient during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-208-4540CustomerService@BunionBootie.com

Regulatory Flags#

DUNS number
078436895
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04518227055629BunionETTE BootieLargeRight2020-08-01
04518227055636BunionETTE BootieMediumRight2020-08-01
04518227055643BunionETTE BootieSmallRight2020-08-01
04518227055674BunionETTE BootieLargeLeft2020-08-01
04518227055681BunionETTE BootieMediumLeft2020-08-01
04518227055698BunionETTE BootieSmallLeft2020-08-01
04518227081918Bunion BootieXLargeRight2020-08-01
04518227081932Bunion BootieMediumRight2020-08-01
04518227081949Bunion BootieSmallRight2020-08-01
04518227081956Bunion BootieXSmallRight2020-08-01
04518227081963Bunion BootieXLargeLeft2020-08-01
04518227081970Bunion BootieLargeLeft2020-08-01
04518227081987Bunion BootieMediumLeft2020-08-01
04518227081994Bunion BootieSmallLeft2020-08-01
04518227082007Bunion BootieXSmallLeft2020-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874682402Tournisec62K SOLUTIONS, LLCILG2025-12-15
00199874723976Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874723973Tournisec62K SOLUTIONS, LLCILG2025-12-15
10199874682409Tournisec62K SOLUTIONS, LLCILG2025-12-15
00818323021783ViveVIVE HEALTH LLCILG2024-09-06
00818323021790ViveVIVE HEALTH LLCILG2024-09-06
10818323021780ViveVIVE HEALTH LLCILG2024-09-06
10818323021797ViveVIVE HEALTH LLCILG2024-09-06
10850053289382SURGYCOSurgyco LLCILG2023-12-15
10850053289399SURGYCOSurgyco LLCILG2023-12-15
10850053289405SURGYCOSurgyco LLCILG2023-12-15
10850053289412SURGYCOSurgyco LLCILG2023-12-15
00850053289385SURGYCOSurgyco LLCILG2023-12-15
00850053289392SURGYCOSurgyco LLCILG2023-12-15
00850053289408SURGYCOSurgyco LLCILG2023-12-15
00850053289415SURGYCOSurgyco LLCILG2023-12-15
00810113570488ViveVIVE HEALTH LLCILG2023-08-23
10810113570485ViveVIVE HEALTH LLCILG2023-08-23
00810113570747ViveVIVE HEALTH LLCILG2022-11-28
10810113570744ViveVIVE HEALTH LLCILG2022-11-28
00818323023503Vive VIVE HEALTH LLCILG2022-10-03
00818323023510Vive VIVE HEALTH LLCILG2022-10-03
10818323023500Vive VIVE HEALTH LLCILG2022-10-03
10818323023517Vive VIVE HEALTH LLCILG2022-10-03
10192253062434CONVERTORSCardinal Health 200, LLCILG2022-09-12
50192253062432CONVERTORSCardinal Health 200, LLCILG2022-09-12
00373317568212AUMSlv Pharmaceuticals LLCILG2022-03-08
00636257031308MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031315MEDIMEDI MANUFACTURING, INC.ILG2021-09-07
00636257031322MEDIMEDI MANUFACTURING, INC.ILG2021-09-07