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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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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

Airo™ CPAP Mask Liners - 20850054813309

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
EVAL-AM-50
In Commercial Distribution

  • 00850054813305 ()
  • 20850054813309 ()
EVAL-AM-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813286

Sample - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
SMPL-AL-50
In Commercial Distribution

  • 00850054813282 ()
  • 20850054813286 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813248

Sample - Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
SMPL-AM-50
In Commercial Distribution

  • 00850054813244 ()
  • 20850054813248 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813200

Sample - Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
SMPL-AS-50
In Commercial Distribution

  • 00850054813206 ()
  • 20850054813200 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 20850054813118

Sample - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
SMPL-AL-50
Not in Commercial Distribution

  • 00850054813114 ()
  • 20850054813118 ()
SMPL-AL-50

  • General-purpose medical fibre padding
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