Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-123514
In Commercial Distribution

  • 06939698601425 ()
PBCS-123514

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-123513
In Commercial Distribution

  • 06939698601418 ()
PBCS-123513

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-108015
In Commercial Distribution

  • 06939698601401 ()
PBCS-108015

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-108014
In Commercial Distribution

  • 06939698601395 ()
PBCS-108014

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-108013
In Commercial Distribution

  • 06939698601388 ()
PBCS-108013

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-105014
In Commercial Distribution

  • 06939698601364 ()
PBCS-105014

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-105013
In Commercial Distribution

  • 06939698601357 ()
PBCS-105013

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-103515
In Commercial Distribution

  • 06939698601340 ()
PBCS-103515

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-103514
In Commercial Distribution

  • 06939698601333 ()
PBCS-103514

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-103513
In Commercial Distribution

  • 06939698601326 ()
PBCS-103513

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-088014
In Commercial Distribution

  • 06939698601302 ()
PBCS-088014

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-088013
In Commercial Distribution

  • 06939698601296 ()
PBCS-088013

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-085015
In Commercial Distribution

  • 06939698601289 ()
PBCS-085015

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-085014
In Commercial Distribution

  • 06939698601272 ()
PBCS-085014

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-085013
In Commercial Distribution

  • 06939698601265 ()
PBCS-085013

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-083515
In Commercial Distribution

  • 06939698601258 ()
PBCS-083515

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-083514
In Commercial Distribution

  • 06939698601241 ()
PBCS-083514

  • Neural-tissue balloon catheter
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.
Shenzhen Shineyard Medical Device Co.,Ltd.
PBCS-083513
In Commercial Distribution

  • 06939698601234 ()
PBCS-083513

  • Neural-tissue balloon catheter
A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography.
OPTOS PUBLIC LIMITED COMPANY
P200TxE
In Commercial Distribution

  • 05057056107509 ()

  • Depth: 570 Millimeter
  • Width: 540 Millimeter
  • Height: 683 Millimeter
A10750

  • Scanning-laser ophthalmoscope/retinal optical coherence tomography system
The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inhalation set, carry case, instructions for use.
VECTURA GROUP PLC
FOX MOBILE Inhalation System (US)
In Commercial Distribution

  • 05056143200031 ()
  • 05056143200048 ()
08CD0010

  • Benchtop nebulizer, non-heated
The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.
VECTURA GROUP PLC
FOX MOBILE Base Unit
In Commercial Distribution

  • 05056143200024 ()
  • 05056143202035 ()
08RS5000

  • Benchtop nebulizer, non-heated
The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
CREO MEDICAL LIMITED
PRD-EMR-050
In Commercial Distribution

  • 05060359561213 ()
  • 05060359561206 ()
PRD-EMR-050

  • Microwave/electrosurgical system generator
The Reusable Interface Cable is only for connection of compatible Creo Medical Instruments (Surgical Accessories) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation via endoscopic access.
CREO MEDICAL LIMITED
PRD-IFC-002
In Commercial Distribution

  • 05060359560629 ()
  • 05060359560834 ()

  • Length: 1.5 Meter
PRD-IFC-002

  • Electrical-only medical device connection cable, reusable
HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following • Peptic Ulcers • Dieulafoy Lesions • Mallory-Weiss Tears • Bleeding Polyp Stalks • Arteriovenous Malformations (AVMs) • Angiomata The HS1 also has irrigation capability. Any other use is not recommended.
CREO MEDICAL LIMITED
Slypseal Flex
In Commercial Distribution

  • 05060359560223 ()
  • 05060359560216 ()

  • Length: 1.8 Meter
  • Outer Diameter: 3.2 Millimeter
7-HS1-001

  • Endoscopic microwave ablation probe/needle
Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
Not in Commercial Distribution

  • 15060216820566 ()
  • 05060216820569 ()


  • Infrared patient thermometer, skin
Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio.
SUN NUCLEAR CORP.
1230000-4Z
In Commercial Distribution

1230000-4Z

  • Accelerator system quality assurance device
Radiation therapy QA device.
SUN NUCLEAR CORP.
1231900Z
In Commercial Distribution

1231900Z

  • Accelerator system quality assurance device
Accessory to the 3D SCANNER Radiation therapy QA device
SUN NUCLEAR CORP.
1231600Z
In Commercial Distribution

  • 05060608880324 ()
1230000-3Z

  • Accelerator system quality assurance device
Radiation Therapy QA Device. For use with the 1230 3D SCANNER.
SUN NUCLEAR CORP.
1203300Z
In Commercial Distribution

12300009Z

  • Accelerator system quality assurance device
Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio
SUN NUCLEAR CORP.
1230680Z
Not in Commercial Distribution

1230000-4Z

  • Accelerator system quality assurance device
Radiation therapy QA device.
SUN NUCLEAR CORP.
1046400Z
In Commercial Distribution

1046000-1Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
1046300Z
In Commercial Distribution

1046000-0Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
1047400Z
In Commercial Distribution

1047000-1Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
1045400Z
In Commercial Distribution

  • 05060608880232 ()
1045000-1Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
1041700Z
In Commercial Distribution

1041000-1Z

  • Solid-state-semiconductor radiation measuring probe
Reference Class Dual-Channel Electrometer Radiation therapy QA device.
SUN NUCLEAR CORP.
1014400Z
In Commercial Distribution

10140001Z

  • Radiation electrometer
Radiation therapy QA device.
SUN NUCLEAR CORP.
1047300Z
In Commercial Distribution

1047000-0Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
1045300Z
In Commercial Distribution

1045000-0Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
1041600Z
In Commercial Distribution

1041000-0Z

  • Solid-state-semiconductor radiation measuring probe
Radiation therapy QA device.
SUN NUCLEAR CORP.
1014300Z
In Commercial Distribution

1014000-0Z

  • Radiation electrometer
Radiation therapy QA device.
SUN NUCLEAR CORP.
1230600Z
In Commercial Distribution

1230000-0Z

  • Accelerator system quality assurance device
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM450P
In Commercial Distribution

  • 05060167129773 ()
450-STR-AS-GW

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • 05060167129735 ()
360-STR-AS-GW

  • Non-rechargeable public automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM350P
In Commercial Distribution

  • 05060167129711 ()
350-STR-AS-GW

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 450P
In Commercial Distribution

  • 05060167128080 ()
450-STR-US-GW

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 360P
In Commercial Distribution

  • 05060167128066 ()
360-STR-US-GW

  • Non-rechargeable public automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • 05060167128042 ()
350-STR-US-GW

  • Non-rechargeable public semi-automated external defibrillator
Battery and Electrode Cartridge
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-07
In Commercial Distribution

PAD-PAK-07

  • Non-rechargeable public semi-automated external defibrillation electrode, adult
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM450P
In Commercial Distribution

  • 05060167120916 ()
450-STR-AS-10

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 360P
In Commercial Distribution

  • 05060167120909 ()
360-STR-AS-10

  • Non-rechargeable public automated external defibrillator
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