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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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中性 - 10697038425188

No Description
HONSUN (NANTONG) CO.,LTD
HS-60A
In Commercial Distribution

  • 10697038425188 ()
  • 00697038425181 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425164

No Description
HONSUN (NANTONG) CO.,LTD
HS-201K1
In Commercial Distribution

  • 10697038425164 ()
  • 00697038425167 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425140

No Description
HONSUN (NANTONG) CO.,LTD
HS-20A
In Commercial Distribution

  • 10697038425140 ()
  • 00697038425143 ()


  • Aneroid manual sphygmomanometer

Unimed - 06945664824972

SpO2 interface cable/安维生-Philips/3.0M/087
Unimed Medical Supplies, Inc.
U710-169
In Commercial Distribution

  • 06945664824972 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664824958

SpO2 interface cable/安维生-Nellcor/3.0M/103X
Unimed Medical Supplies, Inc.
U710-170
In Commercial Distribution

  • 06945664824958 ()


  • Electrical-only medical device connection cable, reusable

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™ SpO2 disposable sensor sample pack - 10843997010358

No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use

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

No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • 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 - 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 - 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 - 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

ViperWire Advance FlexTip - 10852528005725

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FLEX18
In Commercial Distribution

  • 30852528005729 ()
  • 10852528005725 ()

  • Max Tip Diameter 0.018 inches
7-10041-04

  • Peripheral vascular guidewire, manual

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

Diamondback Peripheral - 10852528005008

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

  • 10852528005008 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 180cm
  • Nose Length: 30mm
  • Crown Diameter: 1.75mm
7-10031-09

  • Mechanical atherectomy system catheter, peripheral

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 - 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 - 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 - 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
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