Novo Surgical Inc.

FDA UDI

Class II (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical Inc. FDA UDI
Generic Name: Cannula clamp FDA UDI
Device Name: Insert only, Fenestrated Clamp, 5.0 mm sheath diameter, 40.0 mm jaw length, double action, 13" (33.0 cm), 3-piece modular system (reusable) FDA UDI
Model / Reference: 9000-28213RM FDA UDI
Description: Insert only, Fenestrated Clamp, 5.0 mm sheath diameter, 40.0 mm jaw length, double action, 13" (33.0 cm), 3-piece modular system (reusable) FDA UDI

Identifiers

Catalog Number: 9000-28213RM FDA UDI
Primary DI / UDI-DI: 00842331190155 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Cannula clamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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: Cannula clamp

Novo Surgical Inc. by Novo Surgical, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Novo Surgical, Inc.

Sources (1)

FDA UDI 2c2963e4-399d-4fd1-907b-aace588fb3e3 35 fields · synced May 30, 2026