Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical Inc. FDA UDI
Generic Name: Wire twister FDA UDI
Device Name: rubio needle holder & wire twister, tungsten carbide, serrated jaws, snub nose, 5" (12.7 cm) FDA UDI
Model / Reference: N4341-31 FDA UDI
Description: rubio needle holder & wire twister, tungsten carbide, serrated jaws, snub nose, 5" (12.7 cm) FDA UDI

Identifiers

Catalog Number: N4341-31 FDA UDI
Primary DI / UDI-DI: 00842331128622 FDA UDI
FDA Product Code: HXK FDA UDI
GMDN Term: Wire twister 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Wire twister

Novo Surgical Inc. by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wire twister.

NEW ORLEANS WIRE TWISTER — SONTEC INSTRUMENTS, INC. · Class I
ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
Sklar® — Sklar Corporation · Class I
A&E Medical / Wire Twister — A & E MEDICAL CORPORATION · Class I
NEW ORLEANS WIRE TWISTER — SONTEC INSTRUMENTS, INC. · Class I
MCGEE WIRE CLOSURE FORCEPS — SONTEC INSTRUMENTS, INC. · Class I
Life Instruments — Life Instrument Corporation · Class I
Life Instruments — Life Instrument Corporation · Class I

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: Novo Surgical, Inc.

Sources (1)

FDA UDI b9e7b26d-2a71-40e3-bad2-e4c5a253b679 35 fields · synced May 30, 2026