Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058602

FEI Number

1000219614

Entity Name

OWEN MUMFORD USA, INC.

City/State/Country

MARIETTA, GA, US

Establishment Address

1755 W Oak Commons Ct, MARIETTA, GA 30062, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

OWEN MUMFORD, LTD. (Owner Number: 8021764)

Owner / Operator Contact Address

Primsdown Industrial Estate, Chipping Norton, OXFORDSHIRE, GB-NOTA 0X7 5XP, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Unifine SafeControl Unifine Ultra Autolet Autolet Lite Unilet Unilet ComforTouch Unistik Touch Amielle Unistik TinyTouch - Preemie Unistik HeelStik - Preemie Unistik HeelStik - MicroPreemie Unistik HeelStik - Toddler Unistik HeelStik - Full Term Unistik TinyTouch - Full-Term Unistik 3 Unistik Betaject Lite Extavia Auto-Injector II AUTOJECT 2 (NON-FIXED NEEDLE) NEUROPEN NEUROTIP Unifine Pentips Unifine Pentips Plus Unifine SafeControl Unistik Touch Unistik 3 Unistik Pro Autolet Plus Unilet ComforTouch Unistik TinyTouch Autolet Unilet Constriction Ring size 7 RAPPORT V.T.D. Constriction Ring size 5 Constriction Ring size 4 Constriction Ring size 6 Constriction Ring size 3 Constriction Ring size 8 Constriction Ring size 9 Autopen Classic 3ml Unistik Vacuflip Unistik Shieldlock AUTOSQUEEZE AUTODROP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-09-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-11-01
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-10-17
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-10-17
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-09-21
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2025-07-21
KXP	Stent, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2007-10-31
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-01-09
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-09-21
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	1992-12-02
GXB	Esthesiometer	Neurology	Class 1	882.1500	1992-12-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-06-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-10-11
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	1992-12-02
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	1997-11-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2006-12-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-08-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-08-14
KCM	Dropper, Ent	Ear, Nose, Throat	Class 1	874.5220	1992-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OWEN MUMFORD, LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038110468	Owen Mumford Limited	Witney Oxfordshire, GB
3003348846	Owen Mumford Limited	Chipping Norton Oxfordshire, GB
8021764	OWEN MUMFORD, LTD.	WOODSTOCK, OXFORDSHIRE, GB
3013143994	Owen Mumford Sdn Bhd	Iskandar Puteri Johor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058602. Last updated year: 2026. Please use registration number 1058602 when referencing this establishment in official correspondence.