0.045" x 6" K-Wire Standard

FDA UDI

Class II (US FDA UDI)

by Trilliant Surgical LLC

Identity

Trade Name: 0.045" x 6" K-Wire Standard FDA UDI
Generic Name: Bone access channel kit FDA UDI
Model / Reference: 210-40-004 FDA UDI

Identifiers

Primary DI / UDI-DI: M970210400040 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Bone access channel kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone access channel kit

0.045" x 6" K-Wire Standard by Trilliant Surgical LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Trilliant Surgical LLC

Sources (1)

FDA UDI bd82d0e8-8b28-457a-a118-03a216a5db21 32 fields · synced May 30, 2026