Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009542933

FEI Number

3009542933

Entity Name

GD Group USA Company

City/State/Country

Bartlett, IL, US

Establishment Address

1286 Humbracht Cir, Bartlett, IL 60103, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GD Group USA Company (Owner Number: 10040438)

Owner / Operator Contact Address

1286 Humbracht Circle Suite A, Bartlett, IL 60103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FIBER, MEDICAL, ABSORBENT CAP, SURGICAL Counter, sponge, surgical Drape, Surgical, Exempt DRAPE, SURGICAL BANDAGE, ELASTIC COVER, SHOE, OPERATING-ROOM COTTON, ROLL GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE Non-surgical isolation gown DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

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	2012-04-13
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2012-04-13
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2012-04-13
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-14
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2012-04-13
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-04-13
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2012-04-13
EFN	Cotton, Roll	Dental	Class 1	872.6050	2012-04-13
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2012-04-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-04-13
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-04-13

Official Correspondent

Guangyu Zhang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GD Group USA Company

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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
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 3009542933. Last updated year: 2026. Please use registration number 3009542933 when referencing this establishment in official correspondence.