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VersaOne

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
VersaOne FDA UDI
Generic Name
Laparoscopic multi-instrument access port, single-use FDA UDI
Device Name
Reusable Positioning Cannula FDA UDI
Model / Reference
RC8STS FDA UDI
Description
Reusable Positioning Cannula FDA UDI

Identifiers

Primary DI / UDI-DI
10884521784024 FDA UDI
510(k) Number
K201805 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic multi-instrument access port, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 8 Millimeter FDA UDI

Category: Laparoscopic multi-instrument access port, single-use

VersaOne by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic multi-instrument access port, single-use.

Cleared under the same submission

K201805 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 9e1acecf-428a-4740-b5fd-1dcba187a574 36 fields · synced May 31, 2026