Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043817

FEI Number

3003094575

Entity Name

MICROTEK DOMINICANA, S.A.S.

City/State/Country

LA ROMANA, DO

Establishment Address

ZONA FRANCA II, LA ROMANA 22000, DO

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Accessory to Hospira Device Unna Medline Elastic Bandage Unna-Z CURAD Threeflex Bandages Fourflex Medline Elastic Retention Netting CoFlex LF2 Medline Stockinette CoFlex Sure-Wrap Elastic Bandage ACCU-SORB Matrix Microtek Esmark TwoFlex Accu-Wrap Integra Medline Reusable Non-Sterile Back Surgical Table Covers 171415-O.R. KIT CSTM LEG ANKLE WRIST AND ARM STRAPS Stabilization/Positioner Kit MEDLINE Accessories, operating-room, table (kit) - FWZ Misonix Irrigation Tube Set MRI Interventions Depuy Parker, Eclipse Probe Cover Depuy LifeLiner BERMAN AIRWAYS MEDLINE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY - CAE DYNACOR AIRWAYS "Salt Airway S.A.L.T." VARIOUS SIZES DYNACOR AIRWAYS Medline Hard Guedel Airway Bayer Merit Protection Plus Disposable Underpads Medline Disposable Underpads FitRight Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads OREX MEDICAL BEDDING DISPOSABLE BEDDING CleanOp: bedding and cleaning supplies Microtek Disposable Baby Blanket Extrasorb MICROTEK DISPOSABLE BEDDING FitRight Extended Use Underpad BEDDING Ultrasorb MEDICAL GENERAL HOSPITAL ComfortGlide Drypad Rolled Probe Cover Phillips Intestine Bag Microtek Intestine Bag C.R. Bard Navarre Ocular Occluder DePuy Safety frames / lens Microtek Drape Armour Donjoy DJO LLC CryoCube Medline Gravity Cooler DePuy Medline Orbis LVL 3 Surgical Gown Medline InfraredX Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes Microtek Medline Light Handle Cover MedFix EZ Sorbaview Polar Dressing CURAD SureSite Roll Medline Bordered Gauze Gentac EZ MedFix StickRight CURAD Naturals Stickright Pinc Lingeman Medline 5-in-1 connector Medline Connecting Tubing MEDLINE TUBE, ASPIRATING, FLEXIBLE, CONNECTING - BYY DYNACOR SUCTION CONNECTING TUBING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-10-31
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-02-01
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2024-10-31
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2006-07-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-10-30
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2024-10-31
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2024-10-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-10-31
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-10-31
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2005-02-01
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-10-30
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2024-10-31
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-10-20
JOP	Transducer, Ultrasonic	Cardiovascular	Class 2	870.2880	2024-10-30
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2024-10-30
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2024-10-31
HMT	Drape, Patient, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2024-10-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-10-30
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2015-01-13
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2024-10-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-10-31
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-05-20
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Cardiovascular	Class 2	870.1200	2024-10-30
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-10-30
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-10-30
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2018-03-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-02-07
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2005-02-01

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

Similar Registrations

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3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
9616683	TELEFLEX MEDICAL	ANNACOTTY Limerick, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043817. Last updated year: 2026. Please use registration number 8043817 when referencing this establishment in official correspondence.