Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical Inc. FDA UDI
Generic Name: Ring cutter FDA UDI
Device Name: zenith mcivor mouth gag blades, #2, 24.0 mm x 90.0 mm FDA UDI
Model / Reference: E95664-23 FDA UDI
Description: zenith mcivor mouth gag blades, #2, 24.0 mm x 90.0 mm FDA UDI

Identifiers

Catalog Number: E95664-23 FDA UDI
Primary DI / UDI-DI: 00842331179884 FDA UDI
FDA Product Code: KBN FDA UDI
GMDN Term: Ring cutter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 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: Ring cutter

Novo Surgical Inc. by Novo Surgical, Inc. — 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: Novo Surgical, Inc.

Sources (1)

FDA UDI b24333ad-add5-486d-acf7-bcb8cd367df2 35 fields · synced Jun 1, 2026