Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013949389

FEI Number

3013949389

Entity Name

BLUEPOINT LABORATORIES

City/State/Country

Cork Munster, IE

Establishment Address

8 Eastgate Avenue, Little Island, Cork Munster 0000, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BluePoint Laboratories (Owner Number: 10055637)

Owner / Operator Contact Address

8 Eastgate Avenue, Little Island, Cork, IE-M 0000, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AmerisourceBergen X-Ray Detectable Gauze Sponges

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2018-08-20

Official Correspondent

Carolyn Gannon

US Agent Details

James Miller Business: Cencora Email: jmiller2@mwianimalhealth.com Phone: (913) 2138544

Related Public Records

Same Entity

BluePoint Laboratories

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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013949389. Last updated year: 2026. Please use registration number 3013949389 when referencing this establishment in official correspondence.