T-Handle Chuck

FDA UDI

Class II (US FDA UDI)

by Curvafix Inc

Identity

Trade Name: T-Handle Chuck FDA UDI
Generic Name: Manual wire driver FDA UDI
Device Name: A hand-held manual surgical instrument designed to drive the CurvaFix Steerable Guide into the intramedullary space. FDA UDI
Model / Reference: SGC-001 FDA UDI
Description: A hand-held manual surgical instrument designed to drive the CurvaFix Steerable Guide into the intramedullary space. FDA UDI

Identifiers

Catalog Number: SGC-001 FDA UDI
Primary DI / UDI-DI: 10855068008232 FDA UDI
FDA Product Code: LHX FDA UDI
GMDN Term: Manual wire driver FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5800 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: Manual wire driver

T-Handle Chuck by Curvafix Inc — 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: Curvafix Inc

Sources (1)

FDA UDI 303e8e77-66bd-44b0-adfb-380edef5c451 35 fields · synced Jun 8, 2026