Kii® Optical Access System

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: Kii® Optical Access System FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: Trocars FDA UDI
Model / Reference: C0R39 FDA UDI
Description: Trocars FDA UDI

Identifiers

Primary DI / UDI-DI: 00607915116446 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Laparoscopic access cannula, single-use 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

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 150 Millimeter FDA UDI
Lumen/Inner Diameter — 15 Millimeter FDA UDI

Category: Laparoscopic access cannula, single-use

Kii® Optical Access System by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Laparoscopic access cannula, single-use.

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Versaport — Covidien LP · 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

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI b5a79438-71e6-47ad-ae6a-ec8155e2e001 35 fields · synced Jun 8, 2026