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BunionETTE Bootie

FDA UDI

Class I (US FDA UDI)

by Slo Living Llc

Identity

Trade Name
BunionETTE Bootie FDA UDI
Generic Name
Hallux valgus metatarsophalangeal orthosis FDA UDI
Device Name
Soft, ultra-thin, flexible orthotic for bunions (hallux valgus) and bunionettes (tailor's bunion). The full coverage toe hood covers the big toe and is secured with a heel strap. FDA UDI
Model / Reference
LargeRight FDA UDI
Description
Soft, ultra-thin, flexible orthotic for bunions (hallux valgus) and bunionettes (tailor's bunion). The full coverage toe hood covers the big toe and is secured with a heel strap. FDA UDI

Identifiers

Primary DI / UDI-DI
04518227055629 FDA UDI
FDA Product Code
ILG FDA UDI
GMDN Term
Hallux valgus metatarsophalangeal orthosis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hallux valgus metatarsophalangeal orthosis

BunionETTE Bootie by Slo Living Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hallux valgus metatarsophalangeal orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Slo Living Llc

Sources (1)

  • FDA UDI fba7408b-dcb9-47fe-878e-bd267ae1ca3e 34 fields · synced May 29, 2026