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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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UbiqVue Multiparameter - B353UB15501

1AX Wearable Biosensor
Lifesignals, Inc.
UB1550
In Commercial Distribution

  • B353UB15501 ()
  • B353UB15502 ()
  • B353UB15503 ()


  • Wearable multiple physiological parameter recorder, reusable

VistaPosition Bitewing - E24721301004160

No Description
DÜRR DENTAL SE
RWT01.2A1
In Commercial Distribution

  • E24721301004160 ()
  • E247G37201 ()
  • E247G38201 ()


  • Dental x-ray film holder, reusable

VistaPosition Endo - E24721301004150

No Description
DÜRR DENTAL SE
RWT01.3A1
In Commercial Distribution

  • E24721301004150 ()
  • E247G37301 ()
  • E247G38301 ()
2130100415

  • Dental x-ray film holder, reusable

Control RX-LP Mechanical Thrombectomy System, 136cm - B090ARXLP60

The Control RX-LP Mechanical Thrombectomy Catheter and Control Mechanical Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ARX-LP6
In Commercial Distribution

  • B090ARXLP62 ()
  • B090ARXLP61 ()
  • B090ARXLP60 ()
ARX-LP6

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 6F Mechanical Thrombectomy System 135cm - B090A61350

The Control 5-6F Mechanical Thrombectomy System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A6-135
In Commercial Distribution

  • B090A61352 ()
  • B090A61351 ()
  • B090A61350 ()
A6-135

  • Thrombectomy suction catheter
  • General-purpose syringe, single-use

Aspire Max 6 Aspiration Catheter 55cm - B090A60550

ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A6-055
Not in Commercial Distribution

  • B090A60550 ()
  • B090A60551 ()
  • B090A60552 ()
A6-055

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control 5F Mechanical Thrombectomy System 135cm - B090A51350

The Control 5-6F Mechanical Thrombectomy System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-135
In Commercial Distribution

  • B090A51352 ()
  • B090A51351 ()
  • B090A51350 ()
A5-135

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Aspire Max 5 Aspiration Catheter 55cm - B090A50550

ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-055
Not in Commercial Distribution

  • B090A50552 ()
  • B090A50551 ()
  • B090A50550 ()
A5-055

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter

Control Mechanical Aspirator - B09030ASP0

The Control Mechanical Aspirator is intended to aspirate fluids from the body.
ZIEN MEDICAL TECHNOLOGIES, INC.
30-ASP
In Commercial Distribution

  • B09030ASP0 ()
  • B09030ASP1 ()
  • B09030ASP2 ()
30-ASP

  • General-purpose syringe, single-use

Sterex - M992ULTR283

Safety Lancet 28G*1.8mm
Carelife (usa) Inc.
1
In Commercial Distribution

  • M992ULTR285 ()
  • M992ULTR283 ()
  • M992ULTR280 ()

  • Needle Gauge: 28 Gauge
ULTR28

  • Manual blood lancing device, single-use
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