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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
wire twister, tungsten carbide inserts, 6" (15.2 cm), delicate tips FDA UDI
Model / Reference
N4323-21 FDA UDI
Description
wire twister, tungsten carbide inserts, 6" (15.2 cm), delicate tips FDA UDI

Identifiers

Catalog Number
N4323-21 FDA UDI
Primary DI / UDI-DI
00842331162039 FDA UDI
FDA Product Code
HXS 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Surgical, Inc.

Sources (1)

  • FDA UDI 6cbbcd95-3b6d-4b9d-b61c-a00a3626c054 35 fields · synced May 30, 2026