Novo Surgical

FDA UDI

Class II (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Vascular dilator, reusable FDA UDI
Device Name: Cooley Coronary Dilators, aluminum, malleable shaft, 5" (12.5 cm), 3.0 mm shaft FDA UDI
Model / Reference: C6682-41 FDA UDI
Description: Cooley Coronary Dilators, aluminum, malleable shaft, 5" (12.5 cm), 3.0 mm shaft FDA UDI

Identifiers

Primary DI / UDI-DI: 00842331122767 FDA UDI
FDA Product Code: DWP FDA UDI
GMDN Term: Vascular dilator, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Dimensions & Sizes

Size: Length — 12.5 Centimeter FDA UDI

Category: Vascular dilator, reusable

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

Similar devices

Also classified as Vascular dilator, reusable.

Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
HNM MEDICAL — HNM STAINLESS, LLC. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Dilator, Vascular, Memory 20cm 1.0mm alu-handle RED — Geister Medizin Technik GmbH · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Novo Surgical, Inc.

Sources (1)

FDA UDI 4d4de8a3-2b4a-4f1a-97f8-505361ccc50b 35 fields · synced May 30, 2026