Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1627186

FEI Number

1627186

Entity Name

Lone Star Medical Products

City/State/Country

Stafford, TX, US

Establishment Address

11211 Cash Rd, Stafford, TX 77477, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COOPERSURGICAL, INC. (Owner Number: 9002384)

Owner / Operator Contact Address

95 CORPORATE DRIVE, --, Trumbull, CT 06611, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RUMI System [Mfg] RUMI II & RUMI Arch II Handles [SD] RUMI II & RUMI Arch II Handles [Mfg] Advincula Delineator Flexible Soft Cup Inserter, Inguinal Reservoir

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2008-03-17
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2020-06-11
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2007-12-06

Official Correspondent

Brian Szeremeta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COOPERSURGICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611604	LEISEGANG FEINMECHANIK-OPTIK GMBH	BERLIN, DE
8010251	HBH MEDIZINTECHNIK GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3014755376	CooperSurgical Distribution B.V.	Herten Limburg, NL
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR

Similar Registrations

Registration Number	Establishment Name	Location
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
1321175	BATES INDUSTRIES	S Glens Falls, NY, US
3010131137	BIOTRONIX HEALTHCARE INDUSTRIES INC.	Orlando, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1627186. Last updated year: 2026. Please use registration number 1627186 when referencing this establishment in official correspondence.