Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013046958

FEI Number

3013046958

Entity Name

Premier Guard Zhongshan Limited

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

No 52, Huan Mao Yi Road, Torch Development Zone, Zhongshan Guangdong 528400, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Premier Guard Global Limited (Owner Number: 9031832)

Owner / Operator Contact Address

10320 Lake Road, Suite 101, Houston, TX 77070, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retainer, Surgical: RMD3202, 3204, 3206, 3206 Premier Guard Needle Guide Premier Guard Face Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2006-03-10
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2005-10-12
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-06-06
MMP	Cover, Barrier, Protective	General, Plastic Surgery	Class 2	878.4370	2005-07-27
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-08-31
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2007-10-19
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2006-03-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-03-29
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-03-10

Official Correspondent

Ross Walker

US Agent Details

Ross Walker Business: Premier Guard Global Limited Email: rwalker@premierguard.com Phone: (713) 8617550

Related Public Records

Same Entity

Premier Guard Global Limited

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013046958. Last updated year: 2026. Please use registration number 3013046958 when referencing this establishment in official correspondence.