Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027619

FEI Number

2027619

Entity Name

EAGLE LABS, LLC

City/State/Country

Saint Paul, MN, US

Establishment Address

815 Vikings Pkwy, Ste 160, Saint Paul, MN 55121, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Eagle Labs, LLC (Owner Number: 2027619)

Owner / Operator Contact Address

815 Vikings Pkwy, Ste 160, --, Saint Paul, MN 55121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eyecell NetCell Vitrectomy Lens

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2017-01-19
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-07-17
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2013-01-07
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Ophthalmic	Class 2	886.1385	2017-01-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eagle Labs, 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
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

Similar Registrations

Registration Number	Establishment Name	Location
1932180	Bausch & Lomb Incorporated	Manchester, MO, US
3009337401	Synergy Health Ede BV	Venlo Limburg, NL
3015542130	Nutek Bravo, Hayward	Hayward, CA, US
3006380247	MEDETZ SURGICAL INSTRUMENTS	Jupiter, FL, US
3030516433	ENDONEST MEDICAL SYSTEMS LLP	PALGHAR Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027619. Last updated year: 2026. Please use registration number 2027619 when referencing this establishment in official correspondence.