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Core Dynamics

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name
CORE DYNAMICS FDA UDI
Generic Name
Laparoscopic access cannula seal reducer, single-use FDA UDI
Device Name
5mm Entree II Cannula Valve FDA UDI
Model / Reference
CD650 FDA UDI
Description
5mm Entree II Cannula Valve FDA UDI

Identifiers

Catalog Number
CD650 FDA UDI
Primary DI / UDI-DI
20653405045929 FDA UDI
510(k) Number
K950457 FDA UDI
FDA Product Code
HET FDA UDI
GMDN Term
Laparoscopic access cannula seal reducer, 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5 Millimeter FDA UDI

Category: Laparoscopic access cannula seal reducer, 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 access cannula seal reducer, single-use.

Cleared under the same submission

K950457 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conmed Corporation

Sources (1)

  • FDA UDI 596275db-5be7-4317-9b4a-54c505bae4c4 37 fields · synced Jun 8, 2026