Core Dynamics

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: CORE DYNAMICS FDA UDI
Generic Name: Laparoscopic trocar blade, single-use FDA UDI
Device Name: 5.5mm ENTREE® Plus Trocar FDA UDI
Model / Reference: CD5055P FDA UDI
Description: 5.5mm ENTREE® Plus Trocar FDA UDI

Identifiers

Catalog Number: CD5055P FDA UDI
Primary DI / UDI-DI: 20653405045769 FDA UDI
510(k) Number: K901407 FDA UDI
FDA Product Code: HET FDA UDI
GMDN Term: Laparoscopic trocar blade, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1720 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

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.5 Millimeter FDA UDI
Length — 100 Millimeter FDA UDI

Category: Laparoscopic trocar blade, single-use

Core Dynamics by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic trocar blade, single-use.

PERCUVANCE — TELEFLEX INCORPORATED · Class II
Xpan Universal Trocar System — Xpan, Inc. · Class II
WECK VISTA — Intuitive Surgical, Inc. · Class II
WECK VISTA — Intuitive Surgical, Inc. · Class II
TAUT — TELEFLEX INCORPORATED · Class II
WECK VISTA — Intuitive Surgical, Inc. · Class II
WECK VISTA — Intuitive Surgical, Inc. · Class II
Xpan Universal Trocar System — Xpan, Inc. · Class II

Cleared under the same submission

K901407 also covers:

CORE DYNAMICS — Conmed Corporation

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: Conmed Corporation

Sources (1)

FDA UDI c61038d1-1b28-45aa-a178-36ceec4d272f 37 fields · synced Jun 7, 2026