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 trocar is a solid stainless needle used with cannula to close or block up the cannula opening. The trocar is identical to the obturator except the distal end is sharp whose purpose is to be able to cut into muscle/tendon. The trocar 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: IE58TR FDA UDI
Description: The trocar is a solid stainless needle used with cannula to close or block up the cannula opening. The trocar is identical to the obturator except the distal end is sharp whose purpose is to be able to cut into muscle/tendon. The trocar 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: IE58TR FDA UDI
Primary DI / UDI-DI: 00853816008049 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.

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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 9da24251-3051-47c0-914c-614d697395e5 34 fields · synced Jun 8, 2026