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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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Fortrex - 00821684057803

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV10040040
In Commercial Distribution

  • 00821684057803 ()

  • Length: 40 Centimeter
  • Outer Diameter: 10 Millimeter
  • Catheter Gauge: 7 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,8,AT;Rated Burst Pressure,16,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057797

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV09080135
In Commercial Distribution

  • 00821684057797 ()

  • Outer Diameter: 9 Millimeter
  • Length: 135 Centimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057773

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV09080040
In Commercial Distribution

  • 00821684057773 ()

  • Length: 40 Centimeter
  • Outer Diameter: 9 Millimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057766

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV09040135
In Commercial Distribution

  • 00821684057766 ()

  • Outer Diameter: 9 Millimeter
  • Length: 135 Centimeter
  • Catheter Gauge: 7 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057759

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV09040080
In Commercial Distribution

  • 00821684057759 ()

  • Length: 80 Centimeter
  • Outer Diameter: 9 Millimeter
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 7 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057742

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV09040040
In Commercial Distribution

  • 00821684057742 ()

  • Length: 40 Centimeter
  • Outer Diameter: 9 Millimeter
  • Catheter Gauge: 7 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057735

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08100135
In Commercial Distribution

  • 00821684057735 ()

  • Length: 135 Centimeter
  • Outer Diameter: 8 Millimeter
  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057728

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08100080
In Commercial Distribution

  • 00821684057728 ()

  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 6 French
  • Length: 80 Centimeter
  • Outer Diameter: 8 Millimeter


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057711

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08100040
In Commercial Distribution

  • 00821684057711 ()

  • Length: 40 Centimeter
  • Outer Diameter: 8 Millimeter
  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057704

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08080135
In Commercial Distribution

  • 00821684057704 ()

  • Outer Diameter: 8 Millimeter
  • Length: 135 Centimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,19,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057698

0.035 IN OTW PTA Balloon Catheter
Covidien LP
A35HPV08080080
In Commercial Distribution

  • 00821684057698 ()

  • Length: 80 Centimeter
  • Outer Diameter: 8 Millimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,19,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057674

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV08040135
In Commercial Distribution

  • 00821684057674 ()

  • Outer Diameter: 8 Millimeter
  • Length: 135 Centimeter
  • Catheter Gauge: 6 French
  • Balloon Length,40,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,20,AT;


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057643

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV07100135
In Commercial Distribution

  • 00821684057643 ()

  • Outer Diameter: 7 Millimeter
  • Length: 135 Centimeter
  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,20,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057629

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV07100040
In Commercial Distribution

  • 00821684057629 ()

  • Length: 40 Centimeter
  • Outer Diameter: 7 Millimeter
  • Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,20,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

Fortrex - 00821684057612

0.035 OTW PTA Balloon Catheter
Covidien LP
A35HPV07080135
In Commercial Distribution

  • 00821684057612 ()

  • Outer Diameter: 7 Millimeter
  • Length: 135 Centimeter
  • Balloon Length,80,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,20,AT;
  • Catheter Gauge: 6 French


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050385

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020150090
In Commercial Distribution

  • 00821684050385 ()

  • Length: 150 Millimeter
  • Outer Diameter: 2 Millimeter
  • Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

EarlySense® InSight™ - 07290016169393

No Description
EARLYSENSE LTD
Insight at Home
In Commercial Distribution

  • 07290016169393 ()
AME-02021

  • General-purpose multi-parameter bedside monitor

Zirconia Block - 06970402670207

No Description
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Anterior Translucency (AT)
In Commercial Distribution

  • 06970402670207 ()


  • Dental appliance fabrication material, ceramic

ACCUTRANS Disposable Pressure Monitoring Kit - 08886483504257

No Description
BIOPTIMAL INTERNATIONAL PTE. LTD.
AT 4812-3 - 22-000948-21
In Commercial Distribution

  • 08886483504257 ()
22-000948-21

  • Invasive blood pressure transducer set

SEDECAL - 08436046001947

Ceiling Mount X-ray tube stand
SEDECAL
CS NOVA AT
In Commercial Distribution

  • 08436046001947 ()


  • X-ray system tube support, ceiling mounted

SEDECAL - 08436046001916

This Digital Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
MILLENNIUM PLUS AT
In Commercial Distribution

  • 08436046001916 ()


  • Stationary basic diagnostic x-ray system, analogue
  • Stationary basic diagnostic x-ray system, digital

CELLACTOR® - 07630039100544

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.
Storz Medical AG
SC1 Tower (AT)
In Commercial Distribution

  • 07630039100544 ()


  • Hand-held electric massager

NA - ESOT008061

FRS-21 RB-8 AT Forceps, 21 cm long, round handle 8 mm, straight, tip 1.1 mm, atraumatic
S & T AG
FRS-21 RB-8 AT
In Commercial Distribution

  • ESOT008061 ()
00806

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Doctor Smile / Doctor Diode Laser - 08056093611106

Eye protection (LOEWY 004.0) against laser light at 810 nm
LAMBDA SPA
Protective eye wear
In Commercial Distribution

  • 08056093611106 ()
LOEYW004.0

  • Laser beam eye protector, patient
  • Laser beam eye protector, staff

SaliPen - 07290014891005

SaliPen is an electrostimulating device aimed at treating dry mouth.
SALIWELL LTD
OTC
In Commercial Distribution

  • 07290014891005 ()


  • Dry mouth saliva electrical stimulator

MasterPeace - 07350121950542

Table Shield Left. To be placed at 1st operator position.
Texray AB
Table Shield Left
In Commercial Distribution

  • 07350121950542 ()

  • Width: 90 Centimeter
  • Length: 100 Centimeter
TS1050

  • Radiation shielding table drape

Henry Schein - 10304040178055

Pack Lower Extremity F/ Surgical Center of NH at Derry
HENRY SCHEIN, INC.
5703459
In Commercial Distribution

  • 00304040178058 ()
  • 10304040178055 ()
5703459

  • General surgical procedure kit, non-medicated, single-use

Henry Schein - 10304040178048

Pack Gyn Laparoscopy F/ Surgical Center of NH at Derry
HENRY SCHEIN, INC.
5703458
In Commercial Distribution

  • 00304040178041 ()
  • 10304040178048 ()
5703458

  • General surgical procedure kit, non-medicated, single-use

Henry Schein - 10304040178024

Pack T&A F/ Surgical Center of NH at Derry
HENRY SCHEIN, INC.
5703457
In Commercial Distribution

  • 00304040178027 ()
  • 10304040178024 ()
5703457

  • General surgical procedure kit, non-medicated, single-use

Henry Schein - 10304040178000

Pack D&C F/ Surgical Center of NH at Derry
HENRY SCHEIN, INC.
5703455
In Commercial Distribution

  • 00304040178003 ()
  • 10304040178000 ()
5703455

  • General surgical procedure kit, non-medicated, single-use
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