Reusable Ligature Carrier

FDA UDI

Class I (US FDA UDI)

by Well Lead Medical Co., Ltd

Identity

Trade Name: Reusable Ligature Carrier FDA UDI
Generic Name: Orthodontic ligature director FDA UDI
Device Name: 335mm FDA UDI
Model / Reference: U11A010110 FDA UDI
Description: 335mm FDA UDI

Identifiers

Primary DI / UDI-DI: 06936881156625 FDA UDI
FDA Product Code: GEJ FDA UDI
GMDN Term: Orthodontic ligature director FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic ligature director

Reusable Ligature Carrier by Well Lead Medical 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: Well Lead Medical Co., Ltd

Sources (1)

FDA UDI b1f5c141-fef8-4839-b79b-f9a95db13980 33 fields · synced May 31, 2026