Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010193531

FEI Number

3010193531

Entity Name

DAS MEDICAL INTERNATIONAL, SRL

City/State/Country

La Romana, DO

Establishment Address

Industrial Free Zone II, La Romana 22000, DO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DAS Medical International SRL (Owner Number: 10036300)

Owner / Operator Contact Address

Industrial Free Zone II, La Romana, DO-12 22000, DO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250725

PMA Number

N/A

All Registered Proprietary Names

DR2500 AQUABLATION ESSENTIAL DRAPE PACK VC1018B Video Camera Cover W/Blue Elastic Tip 10 X 18 Non-Sterile DRP-201-DO MASTER DRAPE 300 Maestro TM Two-Arm Drape ODM-2038 44" x 60" - Fitted Fluid Warmer Drape, 3.8L 3692 C-Arm cover 36" x 92" 5380W Mini C-Arm Cover, 53 x 80 205 Maestro Coupler, 10 mm, Drape Accessory VC0996 Video Camera/Laser Arm Cover 9 x 96 0986 Band Bag 36 x 12 ODM-1000 Fluid Warmer Drape 44 X 44 0120X Band Bag With Tape Tabs on Corners 36" X 20 4480S C-Arm Cover W/Straps 44 X 80 4440T Band Bag W/Tape 44 x 40 COLUMN DRAPE IS4000 VISION PROBE BAG, IF1000 4th Arm Drape SD-CIR44 Round Basin Drape Assembly SD-REC44 Rectangular Basin Drape Assembly SD-REC60 Solution Warming Drape Extended Frame 44 X 60 SD-XSR44 Solution Warming Drape 44 x 44 OR2-SIS-Drape DC-14-001 C-Arm Drape MRASA0006 Robotic Arm Sterile Drape MRASA0006V02 Robotic Arm Sterile Drape (8EA/CS) MRASA0008V01 Robotic Lower Arm Cart Sterile Drape (60/CS) OTT421-12 Assembly, Stowage Drape MRASA0008V02 Robotic Lower Arm Cart Sterile Drape (60/CS) X9007669 Senhance Articulating Drape SD-XSR66W Surgical Solution Warming Drape 48 x 66 SD-XDISC66 Surgical Solution Warming Drape- Slush Disc 210-002933-00 Cart Equipment Monarch Drape ACC-002 Stylus Cover OTT420-12 ETHICON 3-ARM STERILE DRAPE BVACCE1-000045 Camera Head Drape 9 x 125 1/2 MRASA0008V03 Lower Arm Cart Sterile Drape MR0082 Zeiss MD Microscope Drape, 53 x 82 MRASA0007V02 Robotic Upper Arm Cart Sterile Drape(16EA/CS) SD-DISC66W Surgical Warming and Slush Drape 48 x 66 ML-COV-001 Cover For Magic Leap Controller 2 VC0796 VC Laser Arm Cover W/Blue Elastic Tip, 7 x 96 MUR-000213 Monarch Controller Drape PB-5000 OtoShield Protective Barrier Drape VC0980P VC Laser Arm Drape W/Perf, 9 x 80 MR0120 Zeiss MD Microscope Drape, 53 x 120 0587W C-ARM Cover Pack 1- 9" X 63" Drape 2- 36" x 25" Band Bags DR3500 User Interface Drape MUR-000013 Monarch Drape Kit 0514 Band Bag 5 x 14 DB1008-S Cysto/Urology Drain Bag Sterile W/ 8mm Adapter For Dornier/Siemens Tables SYS-028 DrillCover SteriGo 300-008066-00 PAU Sheath Stabilizer Drape 0284-2 Band Bag (2 products/package) 0888NT Equipment Drape 18 X 24 100EA/Box 4425 Band Bag 44 x 25 4456S C-Arm Cover W/Straps WO/Bands 44 x 56 430013-16 Instrument Arm Drape SP,1-PACK ZR3630 Zeiss Resight Shower Cap Drape 0136 Band Bag 36 x 36 4065 Equipment Cover 40 x 65 VC0796P Video Camera / Laser Arm Cover W/Perf, 7 x 96 PC0796 Probe Cover 7" x 96 M1130- CDK Rampart M1130 Drape PC0548 Probe Cover, 5 x 48, ODM-2066 44" x 60" - Fitted Fluid Warmer Drape 6.6L 2012T Equipment Drape 20 x 12 0785 Cassette Cover 20x 24 5/8 DRP-201-SK Master Drape 0120 Band Bag 36" X 20 PC0512 Probe Cover, 5 x 12 ZO1000T Microscope Drape 40.5" x 105" 0585 Standard C-Arm Cover 36 X 54 0184 Band Bag 36 x 25 HH2000 SPY-SPHI Sterile Drape 4440 Band Bag 44 x 40 MRASA0007V01 Robotic Upper Arm Cart Sterile Drape (16EA/CS) X0008236 Sterile Tape MG0056 Zeiss MD Microscope Drape, 41 x 56 M1128-CDK RAMPART M1128 DRAPE KIT (15 EA/CS) 0786 Cassette Cover 20x40 0586 Long C-Arm Cover 36 X 90 4454X C-Arm Cover W/Extra Gathering Band 44" X 54" SD-DISC66 Combo Drape Assembly 204 Maestro Coupler, 5 mm, Drape Accessory VC0596 VC Laser Arm Cover W/Blue Elastic Tip, 7 x 96 25EA/Box 4120S Extra Long C-Arm cover W/Straps 40.50 X 120 M1128-ODK RAMPART OUS DRAPE KIT (10 EA/CS 2840 Band Bag 28 x 40 0586S Long C-Arm Cover W/Straps 36" x 92" 021655 R1 Arm Drape MRASA0007 Robotic Upper Arm Cart Sterile Drape SD-XSR66 Surgical Solution Warming Drape 44 x 66 VC0596P Video Camera / Laser Arm Cover W/Perf 5 X 96 DRP-100-SK Chair Drape DRP-302-DO Robot Drape DRP-302-SK Robot Drape 70 X 136 PC0524 Probe Cover, 5 x 24, 0484 Band Bag 28 x 12 MRASA0006V01 Robotic Arm Sterile Drape (8EA/CS) SD-DISC48 48x48 Slush Only Drape 0914 Handle Cover/Band Bag 9 x 14 0587W-1 C-Arm Cover 1-70" drape with 2-36" x 25 VC0996PF VC Laser Arm Drape, 9 x 96 W/Perf. X9007635 Senhance Arm Drape, Single Pack ZP6553120 Zeiss 65D Surgical Protection System 53" X 120" 0888M Equipment Drape 18 x 24 W/Two pieces of 1 tape PB1003 Microscope Drape, 20 x 56 536 Tracking Camera Sterile Drape 700003337553 Mako Drape Kit NAUDRPS Banded Bag Dome Kit ZG1007 Microscope Drape 40 1/2" X 56" DRP-100-DO CHAIR DRAPE 0284 Handle Cover/Band Bag 7 x 9 0484-18 Band Bag 28 x 18 DI 5114 Half Bag C-Arm Cover 36 x 80 CA60105T C-Arm Drape 2023 Band Bag 20 x 23 WR0150 Wild Microscope Drape, 53 x 150 4065X Equipment Cover 40 x 65 W/Tape OTT420-14 Ottava Arm Sterile Drape X9007636 Senhance Arm Cover, 3 Pack 300-008064-00 Equipment Drape Monarch Controller MR0150 Zeiss MD Microscope Drape, 53 x 150 WG0105 Wild Microscope Drape, 41 x 105 BVACCE1-000024 Camera Head Drape 9 x 125 1/2 X9007760 Senhance Articulating Drape 300-021365-00 Monarch Controller Equipment Drape, Clamshell 0585B Standard C-Arm Cover 36 X 54 Non-Sterile X0007790 Senhance Articulating Drape OTT420-13 Package Assembly, Drape ZB0096 Microscope Drape 20 x 96 MRASA0006V03 Robotic Arm Sterile Drape 4065MI 3 Pieces Pack 1 - 44" x 25" Band Bag 1- 36" x 44" Drape 1 - 40" X 65" Drape 0141 Band Bag 36 x 41 ZR53120 Full Body Microscope Drape for Zeiss Resight PC0596 Probe Cover, 5 x 96, 202-170-S MECH ARM DOUBLE LAYER DRAPE RE7-4000 Single Eye Surgical Drape MRASA0007V03 Upper Arm Cart Sterile Drape 0384 Handle Cover/Band Bag 5 x 12 0130 Band Bag 36 x 30 MRASA0008 Robotic Lower Arm Cart Sterile Drape X9007768 Senhance Arm Drape, W/ Verification Card X9007763 Senhance USB-C LIA Cable SB-T1-01 Surgibubble Drape X9007769 Senhance Manipulator Arm Drape w/verification Card, 3 Pack 300-008065-00 Equipment Cover CFG Drape SPD-18-001 Lateral and Prone Access Drape WR1010 Wild Microscope Drape, 53 x 96 IFL-18001-A RAMPART IC M1128 DRAPE KIT (10 EA/CS) ODM-1100 Fluid Warmer Drape 44 X 66 0886 Equipment Drape 36 x 44 ZF53120 Zeiss MD Microscope Drape, With Flat Lens 53 x 120 BD92126 Sterile Bar Drape ZB1005 Zeiss OPMI 1 Microscope Drape, 20 x 56 4454 Band Bag 44 x 54 ZF53150 Zeiss MD Microscope Drape, With Flat Lens 53 x 120 4480W Mini C-Arm Cover, 44 x 80 0888 Equipment Drape 18 x 24 0586L Extra Long C-Arm Cover 36"x103" 0586L-R Extra Long C-Arm Cover WO/Bands 53"x106 HH2020 SPY-SPHI Sterile Drape Sterimed/Stericover 210-00092 Box Kit, Drape, Full 210-00094 Mendaera Universal Instrument Interface, Long 210-00091 Box Kit, Drape, Arm 210-00093 Mendaera Universal Instrument Interface, Short Hugo Robotically Assisted Surgery (RAS) System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2024-12-17
EYH	Table, Cysto, Non-Electrical	Gastroenterology, Urology	Class 1	876.4890	2014-02-09
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-08-14
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2015-11-27
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2026-01-14
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-07-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2014-06-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-15
SCV	Modular Electromechanical Surgical System	General, Plastic Surgery	Class 2	878.4964	2025-12-17

Official Correspondent

Leida Rondon

US Agent Details

Alina Goodman Email: agoodman@UFPT.com Phone: (630) 6129282

Related Public Records

Same Entity

DAS Medical International SRL

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
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010193531. Last updated year: 2026. Please use registration number 3010193531 when referencing this establishment in official correspondence.