FDA Registration
Active
🇩🇴 Dominican Republic
DAS MEDICAL INTERNATIONAL, SRL
Reg #: 3010193531
·
FEI: 3010193531
·
Expires 2026
Products
14
Proprietary Names
181
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- DAS MEDICAL INTERNATIONAL, SRL
- Registration Number
- 3010193531
- FEI Number
- 3010193531
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Industrial Free Zone II
- City
- La Romana
- Country
- DO
Regulatory Submissions
- 510(k) Number
- K853044
Owner / Operator
- Firm Name
- DAS Medical International SRL
- Operator Number
- 10036300
- Address
- Industrial Free Zone II
- City
- La Romana
- State
- DO-12
- Postal Code
- 22000
- Country
- DO
- Correspondent
- Leida Rondon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2024-12-17 |
| Table, Cysto, Non-Electrical | EYH | Class 1 | Gastroenterology, Urology | No | 2014-02-09 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2019-08-14 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2015-11-27 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2026-01-14 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-07-02 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2014-06-06 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-07-15 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2025-12-17 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2016-09-02 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-02-26 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2026-04-08 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2023-03-21 |
| Table, Cystometric, Electric | MMZ | Class 2 | Gastroenterology, Urology | No | 2026-01-14 |
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
Parker, Eclipse Probe Cover
CMS-954V Urology Drainbag
CMS-950P Urology Drainbag
CMS-950V Urology Drainbag
CMS-951V Urology Drainbag
CMS-954P Urology Drainbag
CMS-955P Urology Drainbag
CMS-955V Urology Drainbag
CMS-999 Urology Drainbag
Fluid Warmer Unit
C000-1111 Urology Drain Bag
C000-0593 Urology Drain Bag
A800-0310 Protego Pro Kit
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device