Tungsten Carbide Wire Twister 16cm

FDA UDI

Class I (US FDA UDI)

by N S Surgical Company

Identity

Trade Name: Tungsten Carbide Wire Twister 16cm FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: A surgical instrument specifically designed to twist surgical wire after this has been applied to the site in order to tighten the loop or binding that has been made by the surgeon. The loose ends of the wire are inserted into and gripped by the jaws of this device, and the surgeon pulls a handle which spins the spirally grooved centre piece, thereby twisting and tightening the wire. It is typically used in orthopaedic procedures. This is a reusable device. FDA UDI
Model / Reference: 04-034-16 FDA UDI
Description: A surgical instrument specifically designed to twist surgical wire after this has been applied to the site in order to tighten the loop or binding that has been made by the surgeon. The loose ends of the wire are inserted into and gripped by the jaws of this device, and the surgeon pulls a handle which spins the spirally grooved centre piece, thereby twisting and tightening the wire. It is typically used in orthopaedic procedures. This is a reusable device. FDA UDI

Identifiers

Catalog Number: 04-034-16 FDA UDI
Primary DI / UDI-DI: G25004034160 FDA UDI
FDA Product Code: FHQ FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4730 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

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

Dimensions & Sizes

Size: Length — 18 Centimeter FDA UDI
Length — 16 Centimeter FDA UDI

Category: Suturing needle holder, reusable

Tungsten Carbide Wire Twister 16cm by N S Surgical Company — 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: N S Surgical Company

Sources (1)

FDA UDI 96ecb975-4ce4-411f-be50-b76e916da584 35 fields · synced May 30, 2026