Nuvis

FDA UDI

Class I (US FDA UDI)

by Integrated Endoscopy, Inc.

Identity

Trade Name: Nuvis FDA UDI
Generic Name: Arthroscopic access cannula, reusable FDA UDI
Device Name: The obturator is a solid stainless steel needle used with cannula to close or block up the cannula opening. The obturator will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure. FDA UDI
Model / Reference: IE58OB FDA UDI
Description: The obturator is a solid stainless steel needle used with cannula to close or block up the cannula opening. The obturator will be sold as a reusable non-sterile device and distributed independently. Each instrument is cleaned then sterilized by steam autoclave per customer policy and procedure. FDA UDI

Identifiers

Catalog Number: IE58OB FDA UDI
Primary DI / UDI-DI: 00853816008032 FDA UDI
FDA Product Code: NBH FDA UDI
GMDN Term: Arthroscopic access cannula, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1100 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

Category: Arthroscopic access cannula, reusable

Nuvis by Integrated Endoscopy, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic access cannula, reusable.

Arthrex® — Arthrex, Inc. · Class I
INFLOW CANNULA SET — SONTEC INSTRUMENTS, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
INFLOW CANNULA SET — SONTEC INSTRUMENTS, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I
OBTURATOR — SONTEC INSTRUMENTS, INC. · Class I

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: Integrated Endoscopy, Inc.

Sources (1)

FDA UDI ee016a42-92dd-41eb-b494-9204866fcfce 34 fields · synced Jun 8, 2026