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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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IPD - 08435566609312

Scan abutment Non-Engaging Ø 3,3 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566609312 ()
IPD/DB-SN-01

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566609305

Scan abutment Engaging Ø 3,3 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566609305 ()
IPD/DB-SN-00

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566609299

Castable Non-Engaging Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
CA
In Commercial Distribution

  • 08435566609299 ()
IPD/DB-RR-00

  • Dental casting unit

IPD - 08435566609275

Temporary abutment Non-Engaging Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566609275 ()
IPD/DB-PR-07

  • Dental implant suprastructure, temporary, custom-made

IPD - 08435566609244

Cementing abutment Engaging Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
PC
In Commercial Distribution

  • 08435566609244 ()
IPD/DB-PR-00

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566609237

Temporary abutment Non-Engaging Ø 3,3
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566609237 ()
IPD/DB-PN-07

  • Dental implant suprastructure, temporary, custom-made

IPD - 08435566609213

Temporary abutment Engaging Ø 3,3
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566609213 ()
IPD/DB-PN-06

  • Dental implant suprastructure, temporary, custom-made

IPD - 08435566609190

Multi-unit Abutment 30° Ø 4,1 H 4.5
IMPLANT PROTESIS DENTAL 2004 SL
PMA
In Commercial Distribution

  • 08435566609190 ()
IPD/DB-MR-34

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566609183

Multi-unit Abutment 30° Ø 4,1 H 3.5
IMPLANT PROTESIS DENTAL 2004 SL
PMA
In Commercial Distribution

  • 08435566609183 ()
IPD/DB-MR-33

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566609152

Straight Multi-unit Ø 4,1 H 4.5
IMPLANT PROTESIS DENTAL 2004 SL
PMR
In Commercial Distribution

  • 08435566609152 ()
IPD/DB-MR-04

  • Dental implant suprastructure, permanent, preformed

Stealth - 10852528005343

STEALTH, SOLID, 2.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-225
In Commercial Distribution

  • 10852528005343 ()

  • 7 Fr Intro sheath
  • 0.089 inches Max OD
  • Solid Crown type
  • 120 krpm High speed
  • 90 krpm Medium speed
  • 60 krpm Low speed
  • 0.014 inches Guidewire size OD
  • 145 cm Shaft Length
  • 30 mm Nose length
  • 2.25 mm Crown diameter
70056-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005275

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

  • 10852528005275 ()

  • Crown Type, Solid
  • Intro Sheath 6Fr
  • Max OD 0.079 inches
  • High speed 120krpm
  • Medium speed 90krpm
  • Low speed 60krpm
  • Guidewire 0.014 inches
  • Shaft length 145cm
  • Nose length 30mm
  • Crown diameter 2.00mm
DBP–200SOLID145

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005190

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
Not in Commercial Distribution

  • 10852528005190 ()

  • Crown Type, Micro
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 140 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
DBP-125MICRO145

  • Mechanical atherectomy system catheter, peripheral

Diamondback Coronary - 10852528005183

Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FLP
In Commercial Distribution

  • 30852528005187 ()
  • 10852528005183 ()

  • Length; 325cm
  • Max Shaft Diameter; 0.012 inches
  • Max Tip Diameter; 0.014 inches
72010-01

  • Cardiac/peripheral vascular guidewire, single-use

Diamondback Coronary - 10852528005176

CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
Cardiovascular Systems, Inc.
DBEC-150
In Commercial Distribution

  • 10852528005176 ()

  • Intro Sheath; 6Fr
  • Max OD; 0.061 inches
  • High speed; 120krpm
  • Low speed; 80krpm
  • Guidewire size OD; 0.012 inches
  • Shaft length; 135cm
  • Nose length; 10mm
  • Crown diameter; 1.5mm
  • Crown Type, Classic
70058-03

  • Mechanical atherectomy system, coronary, line-powered

Diamondback Coronary - 10852528005169

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

  • 10852528005169 ()

  • Intro Sheath; 6 french
  • Max OD; 0.057 inches
  • High speed; 120 krpm
  • low speed; 80 krpm
  • Guidewire size OD; 0.012 inches
  • Shaft Length; 135 cm
  • Nose Length; 5mm
  • Crown Size; 1.25 mm
  • Crown Type, Classic
70058-02

  • Mechanical atherectomy system, coronary, line-powered

Diamondback Coronary - 10852528005138

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

  • 10852528005138 ()
70057-03

  • Atherectomy system saline/lubricant pump

Viperslide - 10852528005121

VIPERSLIDE, 100ML BAG, 10 PK
Cardiovascular Systems, Inc.
VPR-SLD2
In Commercial Distribution

  • 30852528005125 ()
  • 10852528005121 ()
72031-01

  • Atherectomy system lubricant

ViperTrack - 10852528005114

VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPRTRKMM20
In Commercial Distribution

  • 30852528005118 ()
  • 10852528005114 ()

  • Length: 500 Millimeter
72029-01

  • X-ray film ruler

ViperTrack - 10852528005107

VIPERTRACK, 50 PACK
Cardiovascular Systems, Inc.
VPR-TRK
In Commercial Distribution

  • 30852528005101 ()
  • 10852528005107 ()

  • Length: 30 Centimeter
72014-02

  • X-ray film ruler

ViperTrack - 10852528005091

VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPR-TRK 20
In Commercial Distribution

  • 10852528005091 ()
  • 30852528005095 ()

  • Length: 30 Centimeter
72014-01

  • X-ray film ruler

ViperWire, Advance - 10852528005084

VIPERWIRE, ADVANCE PERIPHERAL, .017" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-17
In Commercial Distribution

  • 30852528005088 ()
  • 10852528005084 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.017 inches
72023-02

  • Peripheral vascular guidewire, manual

ViperWire, Advance - 10852528005077

VIPERWIRE, ADVANCE PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-14
In Commercial Distribution

  • 30852528005071 ()
  • 10852528005077 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
72023-01

  • Peripheral vascular guidewire, manual

Stealth - 10852528005060

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

  • 10852528005060 ()

  • Crown Type, Solid Micro
  • Intro Sheath 6Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown Diameter 1.25 mm
70056-11

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005053

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

  • 10852528005053 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 30 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Solid
70056-06

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005046

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

  • 10852528005046 ()

  • Intro Sheath 6 Fr
  • max OD 0.070 inches
  • 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
  • Crown Type, Solid
70056-04

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005039

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

  • 10852528005039 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • 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 1.25 mm
  • Crown Type, Solid
70056-03

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005022

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

  • 10852528005022 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • 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
  • Crown Type, Classic
70056-02

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005015

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

  • 10852528005015 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • 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
  • Crown Type, Classic
70056-01

  • Mechanical atherectomy system catheter, peripheral

K&FCOPTEE - 06977160620055

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M607
In Commercial Distribution

  • 06977160620055 ()


  • Air-conduction hearing aid, in-the-ear

K&FCOPTEE - 06977160620048

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M609
In Commercial Distribution

  • 06977160620048 ()


  • Air-conduction hearing aid, in-the-ear

K&FCOPTEE - 06977160620031

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M908
In Commercial Distribution

  • 06977160620031 ()


  • Air-conduction hearing aid, behind-the-ear

K&FCOPTEE - 06977160620024

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M802
In Commercial Distribution

  • 06977160620024 ()


  • Air-conduction hearing aid, behind-the-ear

K&FCOPTEE - 06977160620017

No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M606
In Commercial Distribution

  • 06977160620017 ()


  • Air-conduction hearing aid, in-the-ear

EMST150 - 00793573085498

EMST150 expiratory muscle strength trainer (handheld exerciser ).The EMST150 is a calibrated muscle strength trainer designed specifically for individuals who want to increase the strength of their voice,cough and swallow muscles
Aspire Products LLC
150
In Commercial Distribution

  • 00793573085498 ()


  • PEEP valve, reusable

Freezpen® - 15407008484504

No Description
H & O Equipments SA
35g cartridges for Freezpen
In Commercial Distribution

  • 25407008484501 ()
  • 15407008484504 ()
  • 05407008484507 ()
CL-N2O-35G-UBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484306

No Description
H & O Equipments SA
16g cartridges for Freezpen
In Commercial Distribution

  • 25407008484303 ()
  • 15407008484306 ()
  • 05407008484309 ()
CL-N2O-16G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484207

No Description
H & O Equipments SA
16g cartridges for Freezpen
In Commercial Distribution

  • 25407008484204 ()
  • 15407008484207 ()
  • 05407008484200 ()
CL-N2O-16G-BOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484108

No Description
H & O Equipments SA
8g cartridges for Freezpen
In Commercial Distribution

  • 25407008484105 ()
  • 15407008484108 ()
  • 05407008484101 ()
CL-N2O-8G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484009

No Description
H & O Equipments SA
8g cartridges for Freezpen
In Commercial Distribution

  • 25407008484006 ()
  • 15407008484009 ()
  • 05407008484002 ()
CL-N2O-8G-BOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483514

No Description
H & O Equipments SA
Freezpen 35g
In Commercial Distribution

  • 15407008483514 ()
CL-FPU-36

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483507

No Description
H & O Equipments SA
Freezpen 35G
In Commercial Distribution

  • 15407008483507 ()
CL-FPU-35

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483316

No Description
H & O Equipments SA
Freezpen 16g
In Commercial Distribution

  • 15407008483316 ()
CL-FPU-19

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483309

No Description
H & O Equipments SA
Freezpen 16g
In Commercial Distribution

  • 15407008483309 ()
CL-FPU-18

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483118

No Description
H & O Equipments SA
Freezpen 8g
In Commercial Distribution

  • 15407008483118 ()
CL-FPU-03

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483101

No Description
H & O Equipments SA
Freezpen 8g
In Commercial Distribution

  • 15407008483101 ()
CL-FPU-02

  • General cryosurgical system, cryogen gas, mechanical

Breathe Pure - 00810021178363

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178377 ()
  • 00810021178363 ()
  • 20810021178428 ()
  • 30810021178050 ()


  • Infrared patient thermometer, skin

KKmier - 00810021178219

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178216 ()
  • 00810021178219 ()
  • 20810021178220 ()


  • Infrared patient thermometer, skin

WISHDREAM - 00810021178158

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178155 ()
  • 00810021178158 ()
  • 20810021178169 ()


  • Infrared patient thermometer, skin

konjac - 00810021178134

No Description
Dongguan SIMZO Electronic Technology Co., Ltd.
HW-F7
In Commercial Distribution

  • 10810021178131 ()
  • 00810021178134 ()


  • Infrared patient thermometer, skin
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