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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 - 00697038425259

No Description
HONSUN (NANTONG) CO.,LTD
HS-70A
In Commercial Distribution

  • 00697038425259 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425228

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

  • 00697038425228 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425181

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

  • 00697038425181 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425143

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

  • 00697038425143 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425266

No Description
HONSUN (NANTONG) CO.,LTD
HS-70D
In Commercial Distribution

  • 00697038425266 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425198

No Description
HONSUN (NANTONG) CO.,LTD
HS-70B
In Commercial Distribution

  • 00697038425198 ()


  • Aneroid manual sphygmomanometer

中性 - 00697038425167

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

  • 00697038425167 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425263

No Description
HONSUN (NANTONG) CO.,LTD
HS-70D
In Commercial Distribution

  • 10697038425263 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425256

No Description
HONSUN (NANTONG) CO.,LTD
HS-70A
In Commercial Distribution

  • 10697038425256 ()


  • Aneroid manual sphygmomanometer

中性 - 10697038425225

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

  • 10697038425225 ()
  • 00697038425228 ()


  • Aneroid manual sphygmomanometer

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 - 06945664869171

IBP interface cable/华南医电/Edwards/LP5/4.0M
Unimed Medical Supplies, Inc.
BC-HY-ED
In Commercial Distribution

  • 06945664869171 ()


  • Electrical-only medical device connection cable, reusable

Unimed - 06945664802628

SpO2 interface cable/布鲁克/2.2M/131+170/Nellcor
Unimed Medical Supplies, Inc.
U708-63
In Commercial Distribution

  • 06945664802628 ()


  • 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

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

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

No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable

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

No Description
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable

Wirion - 10850000491882

Wirion Embolic Protection System
Cardiovascular Systems, Inc.
WRN-D6
In Commercial Distribution

  • 10850000491882 ()

  • Deployed Filter Unit Length 22.5 mm
  • Deployed Filter Diameter 3.5-6.0 mm
  • Distal tip to strain relief (usable length) - delivery 144 cm
  • Rapid Exchange (RX) length - delivery 38 cm
  • Maximum catheter diameter - delivery 1.14 mm
  • Distal tip to strain relief (usable length) - retrieval 145 cm
  • Rapid Exchange (RX) length - retrieval 31 cm
  • Maximum catheter diameter - retrieval 1.67 mm
7-10078-01

  • Embolic protection filtering guidewire

Diamondback Coronary - 10850000491363

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

  • 10850000491363 ()

  • Crown Diameter: 1.25mm
  • nose length: 5mm
  • shaft length: 135cm
  • guidewire size OD: 0.012 inches
  • low speed: 80krpm
  • high speed: 120krpm
  • Crown Type: Classic
  • Max OD: 0.052 inches
  • Intro Sheath: 6Fr
7-10060-02

  • Mechanical atherectomy system, coronary, line-powered

Diamondback Coronary - 10850000491356

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

  • 10850000491356 ()

  • Crown diameter: 1.25mm
  • nose length: 5mm
  • shaft length: 135cm
  • guidewire size OD: 0.012 inches
  • low speed: 80 krpm
  • high speed: 120 krpm
  • Max OD: 0.0495 inches
  • Intro Sheath: 6 Fr
  • Crown Type: Classic
7-10060-01

  • Mechanical atherectomy system, coronary, line-powered

Stealth - 10850000491349

STEALTH PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-200
In Commercial Distribution

  • 10850000491349 ()

  • Medium Speed 90 krpm
  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • Crown Type Classic
  • High Speed 140 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 20 mm
  • Crown Diameter 2.00 mm
7-10059-09

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491332

STEALTH PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10850000491332 ()

  • 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 Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 15 mm
  • Crown Diameter 1.50 mm
7-10059-08

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491325

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

  • 10850000491325 ()

  • Intro Sheath 5 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
7-10059-07

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491318

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

  • 10850000491318 ()

  • 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 1.5 mm
7-10059-06

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491301

STEALTH Peripheral, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-125
In Commercial Distribution

  • 10850000491301 ()

  • 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 1.5 mm
7-10059-05

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491295

STEALTH PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10850000491295 ()

  • Intro Shealth 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
7-10059-04

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491288

STEALTH PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10850000491288 ()

  • 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 Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.50 mm
7-10059-03

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491271

STEALTH PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10850000491271 ()

  • Intro Sheath 4 Fr
  • Max OD 0.052 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 7 mm
  • Crown Diameter 1.25 mm
7-10059-02

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491264

STEALTH PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-MICRO
In Commercial Distribution

  • 10850000491264 ()

  • Crown Diameter 1.25 mm
  • High Speed 140 krpm
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • Crown Type Micro
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 145 cm
7-10059-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491257

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200CLASS145
In Commercial Distribution

  • 10850000491257 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • high speed: 140 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 20 mm
  • Crown diameter: 2.00 mm
7-10057-09

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491240

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150CLASS145
In Commercial Distribution

  • 10850000491240 ()

  • 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 size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 15 mm
  • Crown diameter: 1.50 mm
7-10057-08

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491233

Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft
Cardiovascular Systems, Inc.
DBP-175SOLID180
In Commercial Distribution

  • 10850000491233 ()

  • Intro Sheath: 5 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
7-10057-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491226

Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-150SOLID200
In Commercial Distribution

  • 10850000491226 ()

  • 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
7-10057-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491219

Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-125SOLID200
In Commercial Distribution

  • 10850000491219 ()

  • 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: 1.25 mm
7-10057-05

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491202

DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200SOLID145
In Commercial Distribution

  • 10850000491202 ()

  • 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
7-10057-04

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491196

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10850000491196 ()

  • 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 size: OD 0.014 inches
  • shaft length: 145 cm
  • nose length: 10 mm
  • Crown diameter: 1.50 mm
7-10057-03

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491189

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10850000491189 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • guidewire size OD: 0.014 inches
  • shaft length: 145 cm
  • nose length: 7 mm
  • Crown diameter: 1.25 mm
7-10057-02

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491172

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
In Commercial Distribution

  • 10850000491172 ()

  • 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
7-10057-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491035

Diamondback Peripheral, Exchangeable Series, Handle Only
Cardiovascular Systems, Inc.
DBP-EX-HANDLE
In Commercial Distribution

  • 10850000491035 ()
7-10032-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491028

Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-200CLA145
In Commercial Distribution

  • 10850000491028 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 20mm
  • Crown Diameter: 2.00mm
7-10031-11

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491011

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Clasic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150CLA145
In Commercial Distribution

  • 10850000491011 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 15mm
  • Crown Diameter: 1.50mm
7-10031-10

  • 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

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
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