Guardian Supporter

FDA UDI

Class I (US FDA UDI)

by Bm Korea Co., Ltd

Identity

Trade Name: Guardian Supporter FDA UDI
Generic Name: Lumbar spine orthosis FDA UDI
Device Name: This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement. FDA UDI
Model / Reference: GCSET-S FDA UDI
Description: This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809818037954 FDA UDI
FDA Product Code: IQE FDA UDI
GMDN Term: Lumbar spine orthosis FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3490 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 1180 Millimeter FDA UDI
Width — 320 Millimeter FDA UDI

Category: Lumbar spine orthosis

Guardian Supporter by Bm Korea Co., Ltd — 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: Bm Korea Co., Ltd

Sources (1)

FDA UDI 57c5d41d-ad06-4842-88b4-2fa713f00336 34 fields · synced May 30, 2026