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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® adult SpO2 disposable sensor - 10843997000465

No Description
MASIMO CORPORATION
1774
In Commercial Distribution

  • 10843997000465 ()
  • 00843997000468 ()


  • Pulse oximeter probe, single-use

Disposable Electrode Serie - 06924274950202

No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥS-F005吹管不粘
In Commercial Distribution

  • 06924274950202 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

Disposable Electrode Serie - 06924274950059

No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥS-T002吹管钨丝
In Commercial Distribution

  • 06924274950059 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

Biotem - 08800036204173

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system

Biotem - 08800036204166

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system

Serial Data Com. Cable Recording-/CARTO® Systems - 04260166371499

No Description
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable

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

No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable

SpO2.COM® adult/neonatal SpO2 disposable sensor - 10843997000496

No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • Pulse oximeter probe, single-use

SpO2.COM™ SpO2 disposable sensor sample pack - 10843997010358

No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use

Diamondback Peripheral - 10852528005992

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL200
In Commercial Distribution

  • 10852528005992 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.50mm
7-10031-08

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005985

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL200
In Commercial Distribution

  • 10852528005985 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.25mm
7-10031-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005978

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid 75 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL75
In Commercial Distribution

  • 10852528005978 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75cm
  • Nose Length: 7mm
  • Crown diameter: 1.25mm
7-10031-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005909

Diamondback Peripheral, Exchangeable Series, 1.50 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-150CLA145
In Commercial Distribution

  • 10852528005909 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 15 mm
  • Crown Diameter: 1.50 mm
7-10030-10

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005893

Diamondback Peripheral, Exchangeable Series, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-175SOL180
In Commercial Distribution

  • 10852528005893 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length:180 cm
  • Nose Length: 30 mm
  • Crown Diameter: 1.75 mm
7-10030-09

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005886

Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-150SOL200
In Commercial Distribution

  • 10852528005886 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.50 mm
7-10030-08

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005879

Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125SOL200
In Commercial Distribution

  • 10852528005879 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.25 mm
7-10030-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005862

Diamondback Peripheral, Exchangeable Series, 1.25 Solid 75 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125SOL75
In Commercial Distribution

  • 10852528005862 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005848

Diamondback Peripheral, Exchangeable Series, 2.00 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-200SOL145
In Commercial Distribution

  • 10852528005848 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 30 mm
  • Crown Diameter: 2.00 mm
7-10030-04

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005831

Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-150SOL145
In Commercial Distribution

  • 10852528005831 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.50 mm
7-10030-03

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005824

Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125SOL145
In Commercial Distribution

  • 10852528005824 ()

  • Guidewire: 0.014 inches
  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-02

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005817

Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125MIC145
In Commercial Distribution

  • 10852528005817 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Coronary - 10852528005787

CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10852528005787 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.057 inches
  • Crown Type: Classic
  • High speed: 120 krpm
  • low speed: 80 krpm
  • guidewire size OD 0.012 inches
  • shaft length: 135 cm
  • nose length: 5 mm
  • Crown diameter: 1.25 mm
70058-13

  • Mechanical atherectomy system, coronary, line-powered

Stealth - 10852528005770

Stealth, Radial Access OAD, 1.75mm, 30mm, 180cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-175
In Commercial Distribution

  • 10852528005770 ()

  • Crown Diameter 1.75 mm
7-10058-03

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005763

Stealth, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-150
In Commercial Distribution

  • 10852528005763 ()

  • Crown Diameter 1.5 mm
7-10058-02

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005756

Stealth, Radial Access OAD, 1.25mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-125
In Commercial Distribution

  • 10852528005756 ()

  • Crown diameter 1.25mm
7-10058-01

  • Mechanical atherectomy system catheter, peripheral

Extended Length ViperWire Advance - 10852528005749

ViperWire, Advance, Flex Tip, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-ELFLEX18
In Commercial Distribution

  • 30852528005743 ()
  • 10852528005749 ()

  • Max Tip Diameter 0.018 inches
7-10041-02

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005732

ViperWire, Advance, , Flex Tip, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-ELFLEX14
In Commercial Distribution

  • 30852528005736 ()
  • 10852528005732 ()

  • Max Tip Diameter 0.014 inches
7-10041-01

  • Peripheral vascular guidewire, manual

ViperWire Advance FlexTip - 10852528005718

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FLEX14
In Commercial Distribution

  • 10852528005718 ()
  • 30852528005712 ()

  • Max Tip Diameter 0.014 inches
7-10041-03

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10852528005701

Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FT
In Commercial Distribution

  • 30852528005705 ()
  • 10852528005701 ()

  • Length 325 cm
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter: 0.014 inches
7-10038-01

  • Cardiac/peripheral vascular guidewire, single-use

ViperCath XC - 10852528005695

200 cm, 0.035" guidewire compatible, support catheter
Cardiovascular Systems, Inc.
035-XC-200-1
In Commercial Distribution

  • 10852528005695 ()

  • Max Outer Diameter: 0.059 inches
  • Inner Diameter: 0.035 inches
  • Length: 200 cm
7-10043-02

  • Vascular guide-catheter, single-use

ViperCath XC - 10852528005688

200 cm, 0.035" guidewire compatible, support catheter
Cardiovascular Systems, Inc.
035-XC-200-0
In Commercial Distribution

  • 10852528005688 ()

  • Max Outer Diameter: 0.059 inches
  • Inner Diameter: 0.035 inches
  • Length: 200 cm
7-10043-01

  • Vascular guide-catheter, single-use

Extended Length ViperWire Advance - 10852528005466

ViperWire, Advance, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL18
In Commercial Distribution

  • 10852528005466 ()
  • 30852528005460 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10035-02

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005459

ViperWire, Advance, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL14
In Commercial Distribution

  • 30852528005453 ()
  • 10852528005459 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10035-01

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10852528005442

SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005442 ()
7-10037-01

  • Atherectomy system saline/lubricant pump

ViperCross - 10850026568155

ViperCross Support Catheter, 018", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-090
In Commercial Distribution

  • 10850026568155 ()

  • Guidewire Compability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 90cm
  • Tip Shape: Straight
7-10093-02

  • Vascular microcatheter

ViperCross - 10850026568148

ViperCross Support Catheter, 018", 65cm Straight
Cardiovascular Systems, Inc.
P1VC-018STR-065
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
In Commercial Distribution

  • 10850026568131 ()

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

  • Vascular microcatheter

ViperCross - 10850026568124

ViperCross Support Catheter, 014", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-135
In Commercial Distribution

  • 10850026568124 ()

  • Guidewire Compatability: 0.014 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10092-01

  • 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

Diamondback Coronary - 10850026568087

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

  • 10850026568087 ()

  • 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 inches
  • Intro Sheath, 6Fr
7-10060-09

  • Mechanical atherectomy system, coronary, line-powered
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