Steins

FDA UDI

Class I (US FDA UDI)

by Dms Holdings, Inc.,

Identity

Trade Name: Steins FDA UDI
Generic Name: Toe separator FDA UDI
Device Name: Stein's Gel Bunion Toe Separators FDA UDI
Model / Reference: 765-3080-0000 FDA UDI
Description: Stein's Gel Bunion Toe Separators FDA UDI

Identifiers

Primary DI / UDI-DI: 00041298993865 FDA UDI
FDA Product Code: KYS FDA UDI
GMDN Term: Toe separator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6280 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Toe separator

Steins by Dms Holdings, Inc., — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Dms Holdings, Inc.,

Sources (1)

FDA UDI 26780533-1a57-43fc-836c-6f8d25c49683 33 fields · synced May 30, 2026