FDA Registration Active 🇮🇱 Israel

MEDIPLAST ISRAEL LTD

Reg #: 3008729892 · FEI: 3002807555 · Expires 2026
Products
42
Proprietary Names
82
Establishment Types
1
Classifications
42

Registration Details

Registration Name
MEDIPLAST ISRAEL LTD
Registration Number
3008729892
FEI Number
3002807555
Status
Active
Expiry Year
2026
Initial Importer
No
Address
7 Ha Yarkon Street, Industrial Area
City
Yavne Tel Aviv
Country
IL

Owner / Operator

Firm Name
Mediplast Israel Ltd.
Operator Number
10042357
Address
7 Ha'Yarkon Street, Industrial Area
City
Yavne
State
Tel Aviv
Postal Code
81227
Country
IL
Correspondent
George Hattub

US Agent

Business Name
Medicsense USA LLC
Contact Name
George Hattub
Address
291 Hillside Ave
City
Somerset
State
MA
ZIP
02726
Country
US
Phone
508 4796116

Products

Device Name Product Code
Bronchoscope (Flexible Or Rigid) EOQ
Fixation, Non-Absorbable Or Absorbable, For Pelvic Use PBQ
Pin, Fixation, Smooth HTY
Hydrogel Spacer OVB
Unit, Cryosurgical, Accessories GEH
Bone Grafting Material, Animal Source NPM
Implanted Tibial Electrical Urinary Continence Device QXM
Set, I.V. Fluid Transfer LHI
Instrument, Manual, Surgical, General Use MDM
Powered Laser Surgical Instrument GEX
Barrier, Animal Source, Intraoral NPL
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Laparoscope, General & Plastic Surgery GCJ
Anti Fog Solution And Accessories, Endoscopy OCT
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
Hook, Ophthalmic HNQ
Staple, Absorbable MNU
Screw, Fixation, Bone HWC
Electrosurgical, Cutting & Coagulation & Accessories GEI
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Guide, Needle, Surgical GDF
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed QPQ
Massager, Vacuum, Light Induced Heating NUV
Massager, Vacuum, Radio Frequency Induced Heat PBX
Massager, Therapeutic, Electric ISA
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures SCZ
Clamp, Vascular DXC
Catheters, Suction, Tracheobronchial BSY
Diagnostic Low Electric Field OEE
Clip, Implantable FZP
Administration Set Securement Device PUK
Needle, Hypodermic, Single Lumen FMI
Mr-Guided Focused Ultrasound System POH
Catheter For Crossing Total Occlusions PDU
Injector, Fluid, Non-Electrically Powered KZE
Instrument, Ent Manual Surgical LRC
Splint, Intranasal Septal LYA
Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia QKA
Mountable Electromechanical Surgical System For Transluminal Approaches QNM
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
Skin Resurfacing Rf Applicator OUH

Proprietary Names

LungVision Tool EnPlace OSSIOfiber® Trimmable Fixation Nail, 4x100mm, Cannulated BioProtect Balloon Implant System IceSphere 1.5 CX Cryoablation needle OSSIX™ Bone Revi Implant Vial2Bag Advanced® 20mm Admixture Device OSSIO® Pin Product Family; OSSIOfiber® Trimmable Fixation Nail Holder IceRod 1.5 CX 90 Cryoablation Needle elos Plus Vial2Bag Advanced® 13mm Admixture Device IceSphere 1.5 90 Cryoablation Needle, IceSphere 1.5 Cryoablation Needle OSSIX® VOLUMAX Name Plasma Shield Disposable Part MG412113- OnGuard Spike Port Adaptor CSTD.US IceForce 2.1 CX L Cryoablation Needle, IcePearl 2.1 CX L Cryoablation Needle APX 200 OSSIOfiber® Trimmable Fixation Nail, Cannulated OSSIOfiber® Compression Staple Closed antineoplastic and hazardous drug reconstitution and transfer system OSSIOfiber® Compression Screw Profound Matrix Cartridges OSSIOfiber® Suture Anchor 2.5-3.5 mm Introducer OSSIOfiber® Suture Anchor OSSIOfiber Compression Staple CO2RE InSpace™ Subacromial Tissue Spacer System VellaShape II V20 System With V-FR Handpiece V10 System With V-FR Handpiece V30 System With V-FR Handpiece EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE IcePearl 2.1 CX Needle, IceForce 2.1 CX Cryoablation Needle OSSIX® PLUS IceRod Plus Needle, IceRod Plus 90 Degree Needle, IceRod Plus 90 Needle ULTRA Pulse Alpha CO2 Laser System, Delivery Devices and Accessories ShortCut Viola OSSIOfiber® Interference Screw CleanSweep Closed Suction System OSSIX Breeze OSSIOfiber® Trimmable Fixation Nail TL10 OSSIOfiber® Threaded Trimmable Fixation Nail MarginProbe Probe MG412166- OnGuard 2 CSTD BAG ADAPTOR CP (BACP) Amsel Occluder Device Administration Set Securement Device Needle, hypodermic, single lumen Xpeeda™ D/S/L; Sterile Aspiration Tubing ProSense Cryoablation console and cryoprobes Exablate 4000 (Exablate Neuro) Proprietary name of the sterilized accessory: PFK (Patient Fixation Kit) Endymed Pro Skin Treatment System; iFine; Shaper3D BeBack Crossing Catheter IceRod 1.5 CX 90 Needle, IceRod CX 90 MultiPack OSSIOfiber® Hammertoe Fixation System; OSSIOfiber® Hammertoe Fixation Implant AirGent eTwo Composite Removable Sinus Stent System iTIND OSSIOfiber Compression Screw, 3.5mm Instrument ARM as part of Hominis Surgical System AcuPulse CO2 Laser System, Delivery Devices and Accessories IceRod Prostate Kit, IceRod Needle, IceRod MRI Needle, IceSeed MRI Needle MG412170- OnGuard 2 CSTD 20mm Vial Adaptor SL and 13mm Convertor MG412160- OnGuard 2 LUER LOCK ADAPTOR MG412164- OnGuard 2 SYRINGE ADAP.LOCK MG412175- OnGuard 2 Vial Adaptor Multipack 10 units MG412174- OnGuard 2 Syringe Adaptor Lock II MG412143- OnGuard 2 BAG ADAPTOR SP MG412177- Onguard 2 Syringe Adaptor Sterile Replacement Caps MG412161- OnGuard 2 20MM VIAL ADAPTOR MG412171- OnGuard 2 CSTD 20mm vial Adaptor II and 13mm convertor MG412186- OnGuard 2 BAG ADAPTOR SP II MG412187- OnGuard 2 Vial Adaptor Multipack 5 units MG412163- OnGuard 2  SYRINGE ADAPTOR Pure by EndyMed Vial2Bag Advanced 20mm Admixture Device

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)