Signex

FDA UDI

Class I (US FDA UDI)

by OSTEONIC CO., Ltd.

Identity

Trade Name: Signex FDA UDI
Generic Name: Surgical instrument torque limiter FDA UDI
Model / Reference: Y7D.15010 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800071017073 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical instrument torque limiter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument torque limiter

Signex by OSTEONIC 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: OSTEONIC CO., Ltd.

Sources (1)

FDA UDI b38659e9-b01e-4d9e-8524-55d574eedd98 32 fields · synced Jun 8, 2026