SEACOLE-CRC, LLC

FDA Device Registration & Listing · Plymouth, MN, US · Registration 3008363932

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008363932
FEI Number
3008363932
Entity Name
SEACOLE-CRC, LLC
City/State/Country
Plymouth, MN, US
Establishment Address
13505 Industrial Park Blvd., Plymouth, MN 55441, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Seacole-CRC, LLC (Owner Number: 10079585)
Owner / Operator Contact Address
13505 Industrial Park Blvd., Plymouth, MN 55441, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Biodrain streamway fluid management system Intercept Wipes

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2024-09-24
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2023-11-30

Official Correspondent

Sara Ethier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Seacole-CRC, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K082762 Aardvark Medical AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE 2008-11-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-05 Kinetic Concepts, Inc 2
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008363932. Last updated year: 2026. Please use registration number 3008363932 when referencing this establishment in official correspondence.
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