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: jennings mouth gag, standard pattern, extra-small (infant), 3 3/4" (9.5 cm) spread FDA UDI
Model / Reference: E8318-10 FDA UDI
Description: jennings mouth gag, standard pattern, extra-small (infant), 3 3/4" (9.5 cm) spread FDA UDI

Identifiers

Catalog Number: E8318-10 FDA UDI
Primary DI / UDI-DI: 00842331167195 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

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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 fb81b567-ec2d-4a81-a981-6a7d24800120 35 fields · synced May 30, 2026