Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1647137

FEI Number

1000306068

Entity Name

RETRACTABLE TECHNOLOGIES, INC.

City/State/Country

Little Elm, TX, US

Establishment Address

511 Lobo Ln, Little Elm, TX 75068, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

RETRACTABLE TECHNOLOGIES, INC. (Owner Number: 9010273)

Owner / Operator Contact Address

511 LOBO LN., --, Little Elm, TX 75068, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K971763

PMA Number

N/A

All Registered Proprietary Names

VanishPoint Syringe Patient Safe Luer Cap VanishPoint IV Catheter VanishPoint Syringe VanishPoint Blood Collection Tube Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2011-03-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-03-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2009-11-12
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2011-03-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-11-08

Official Correspondent

Michele Larios

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RETRACTABLE TECHNOLOGIES, INC.

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
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3012116434	ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.	Taihu Anhui, CN
3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1647137. Last updated year: 2026. Please use registration number 1647137 when referencing this establishment in official correspondence.