Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007305426

FEI Number

3007305426

Entity Name

PREMIER ENTERPRISES

City/State/Country

Virudhunagar Tamil Nadu, IN

Establishment Address

No. 39/2 South St, Sankara Pandiapuram, Virudhunagar Tamil Nadu 626102, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Premier Enterprises (Owner Number: 10027163)

Owner / Operator Contact Address

No. 39/2 South St, Sankara Pandiapuram, Virudhunagar, IN-TN 626102, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cut Gauze, Premier Brand, White, Pure Cotton Gauze Premier Brand, White, Pure Gauze Plain Guaze Swabs Premier Brand, White, Pure Gauze Lap Sponge with X-Ray Detectable Thread & Loop Guaze Swabs with X-Ray Detectable Thread Lap Sponge with Loop Premier Brand, White, Pure Gauze

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2008-10-08
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2008-10-08
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2008-10-08
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2008-10-08

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Premier Enterprises

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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3015068387	GEORGE COUREY INC	Montreal Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007305426. Last updated year: 2026. Please use registration number 3007305426 when referencing this establishment in official correspondence.