← Back to catalogue

Core Dynamics

FDA UDI

Class I (US FDA UDI)

by Conmed Corporation

Identity

Trade Name
CORE DYNAMICS FDA UDI
Generic Name
Laparoscopic access cannula seal, reusable FDA UDI
Device Name
10/12mm Sealing Cap for Entree® Pies Cannula and Reducer Sleeves, Reusable FDA UDI
Model / Reference
CD112B FDA UDI
Description
10/12mm Sealing Cap for Entree® Pies Cannula and Reducer Sleeves, Reusable FDA UDI

Identifiers

Catalog Number
CD112B FDA UDI
Primary DI / UDI-DI
20653405044564 FDA UDI
510(k) Number
K911813 FDA UDI
FDA Product Code
FBM FDA UDI
GMDN Term
Laparoscopic access cannula seal, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5090 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K911813 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Conmed Corporation

Sources (1)

  • FDA UDI 8db086e9-0cda-4ef2-ae80-d66515607186 37 fields · synced Jun 8, 2026