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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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SpO2.COM® RS-1 adult SpO2 reusable sensor - 00843997000505

No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable

S&W - 10854661006294

ECG Electrodes
Leonhard Lang GmbH
FS-TB1 /5 -5
In Commercial Distribution

  • 30854661006298 ()
  • 20854661006291 ()
  • 10854661006294 ()
  • 00854661006297 ()
505

  • Electrocardiographic electrode, single-use

S&W - 10854661006201

ECG Electrodes
Leonhard Lang GmbH
FS-TB /5 -5
In Commercial Distribution

  • 30854661006205 ()
  • 20854661006208 ()
  • 10854661006201 ()
  • 00854661006204 ()
855

  • Electrocardiographic electrode, single-use

S&W - 10854661006010

ECG Electrodes
Leonhard Lang GmbH
FS-TB4 /5 -5
In Commercial Distribution

  • 30854661006014 ()
  • 20854661006017 ()
  • 10854661006010 ()
  • 00854661006013 ()
754/5

  • Electrocardiographic electrode, single-use

Procellera Single Layer - 00810198030808

Procellera Single Layer Rx, 5" x 5"
Vomaris Wound Care, Inc.
5" x 5"
In Commercial Distribution

  • 00894318002579 ()
  • 00810198030808 ()
  • 00810198030815 ()
VSR-0505

  • Bioelectric wound dressing

Shepherd - 10850026568681

0.018" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP18S-30030
In Commercial Distribution

  • 30850026568685 ()
  • 10850026568681 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-08

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568667

0.014" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP14S-30030
In Commercial Distribution

  • 30850026568661 ()
  • 10850026568667 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Hydrophilic Coating
  • Tip Design Polymer Jacket
7-10097-06

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568643

0.018" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP18S-30012
In Commercial Distribution

  • 30850026568647 ()
  • 10850026568643 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-04

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568629

0.014" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-30012
In Commercial Distribution

  • 30850026568623 ()
  • 10850026568629 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-02

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568605

0.018" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-30006
In Commercial Distribution

  • 30850026568609 ()
  • 10850026568605 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydorphilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-08

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568582

0.014" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-30006
In Commercial Distribution

  • 30850026568586 ()
  • 10850026568582 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-06

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568568

0.018" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-30004
In Commercial Distribution

  • 30850026568562 ()
  • 10850026568568 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-04

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568544

0.014" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-30004
In Commercial Distribution

  • 10850026568544 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straighht
  • Tip Design Polymer Jacket
7-10096-02

  • Peripheral vascular guidewire, manual

DIAMONDBACK - 10850026568476

DIAMONDBACK EXCHANGEABLE SYSTEM, 2.00 MAX CROWN, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–EX-200MAX145
In Commercial Distribution

  • 10850026568476 ()

  • Crown Diameter: 2.00 mm
7-10030-13

  • Mechanical atherectomy system catheter, peripheral

DIAMONDBACK - 10850026568445

DIAMONDBACK PERIPHERAL, MAX CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200MAX145
In Commercial Distribution

  • 10850026568445 ()

  • Crown Diameter: 2.00 mm
7-10057-10

  • Mechanical atherectomy system catheter, peripheral

ViperCross - 10850026568247

ViperCross Support Catheter, 035", 135cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-135
Not in Commercial Distribution

  • 10850026568247 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 135cm
  • Tip Shape: Angled
7-10094-07

  • Vascular microcatheter

ViperCross - 10850026568223

ViperCross Support Catheter, 035", 65cm, Angled
Cardiovascular Systems, Inc.
P1VC-035ANG-065
Not in Commercial Distribution

  • 10850026568223 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 65cm
  • Tip Shape: Angled
7-10094-05

  • Vascular microcatheter

ViperCross - 10850026568209

ViperCross Support Catheter, 035", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-135
Not in Commercial Distribution

  • 10850026568209 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10094-03

  • Vascular microcatheter

ViperCross - 10850026568186

ViperCross Support Catheter, 035", 65cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-065
Not in Commercial Distribution

  • 10850026568186 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 65cm
  • Tip Shape: Straight
7-10094-01

  • Vascular microcatheter

ViperCross - 10850026568162

ViperCross Support Catheter, 018", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-135
Not in Commercial Distribution

  • 10850026568162 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10093-03

  • Vascular microcatheter

ViperCross - 10850026568148

ViperCross Support Catheter, 018", 65cm Straight
Cardiovascular Systems, Inc.
P1VC-018STR-065
Not in Commercial Distribution

  • 10850026568148 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 65cm
  • Tip Shape: Straight
7-10093-01

  • Vascular microcatheter

ViperCross - 10850026568131

ViperCross Support Catheter, 014", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-150
Not in Commercial Distribution

  • 10850026568131 ()

  • Guidewire Compability: 0.014 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 150cm
  • Tip Shape: Straight
7-10092-02

  • Vascular microcatheter

Diamondback Coronary - 10850026568100

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568100 ()

  • Crown diameter, 1.25mm
  • Nose Length, 5mm
  • Shaft Length, 135cm
  • Guidewire Size OD, 0.012 inches
  • Low Speed, 80 krpm
  • Medium Speed, krpm
  • High Speed, 120 krpm
  • Crown Type, Classic
  • Max OD, 0.0495
  • Intro Sheath, 6
7-10060-10

  • Mechanical atherectomy system, coronary, line-powered

STEALTH - 10850026568711

STEALTH, 2.00 MAX CROWN, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-MAX-200
In Commercial Distribution

  • 10850026568711 ()

  • Crown Diameter: 2.00 mm
7-10059-46

  • Mechanical atherectomy system catheter, peripheral

Shepherd - 10850026568674

0.018" Shepherd ES Guidewire - straight 195 cm - 30 gms
Cardiovascular Systems, Inc.
PSP18S-19530
In Commercial Distribution

  • 30850026568678 ()
  • 10850026568674 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-07

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568650

0.014" Shepherd ES Guidewire - straight 195 cm - 30 gms
Cardiovascular Systems, Inc.
PSP14S-19530
In Commercial Distribution

  • 30850026568654 ()
  • 10850026568650 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-05

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568636

0.018" Shepherd ES Guidewire - straight 195 cm - 12 gms
Cardiovascular Systems, Inc.
PSP18S-19512
In Commercial Distribution

  • 30850026568630 ()
  • 10850026568636 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-03

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568612

0.014" Shepherd ES Guidewire - straight 195 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-19512
In Commercial Distribution

  • 30850026568616 ()
  • 10850026568612 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-01

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568599

0.018" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-19506
In Commercial Distribution

  • 30850026568593 ()
  • 10850026568599 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrdophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-07

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568575

0.014" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-19506
In Commercial Distribution

  • 30850026568579 ()
  • 10850026568575 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-05

  • Peripheral vascular guidewire, manual
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