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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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XO Score - B090S6250650

The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.25-065
In Commercial Distribution

  • B090S6250650 ()
  • B090S6250651 ()
  • B090S6250652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.25mm
S6.25-065

  • Peripheral angioplasty balloon catheter, basic

PowrSyringe - B090PWR100

The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures.
ZIEN MEDICAL TECHNOLOGIES, INC.
PWR-10
In Commercial Distribution

  • B090PWR101 ()
  • B090PWR100 ()
  • B090PWR102 ()


  • Angiographic syringe

Control 10T Mechanical Thrombectomy System Tubing, Female Suction - B090MT10100F0

The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100-F
In Commercial Distribution

  • B090MT10100F1 ()
  • B090MT10100F0 ()
  • B090MT10100F2 ()
MT10-100-F

  • Thrombectomy tubing set, non-electronic

Control 10T Mechanical Thrombectomy System Tubing, 3-Pack - B090MT1010030

The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100-3
In Commercial Distribution

  • B090MT1010031 ()
  • B090MT1010030 ()
  • B090MT1010032 ()
MT10-100-3

  • Thrombectomy tubing set, non-electronic

Control 10T Mechanical Thrombectomy System Tubing - B090MT101000

The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100
In Commercial Distribution

  • B090MT101000 ()
  • B090MT101001 ()
  • B090MT101002 ()
MT10-100

  • Thrombectomy tubing set, non-electronic

Control 10T Mechanical Thrombectomy Filter - B090MT100

The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10
In Commercial Distribution

  • B090MT101 ()
  • B090MT100 ()
  • B090MT102 ()
MT10

  • Thrombectomy tubing set, non-electronic

LANDMARK - B090LRN0590

The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
ZIEN MEDICAL TECHNOLOGIES, INC.
LR-N-059
In Commercial Distribution

  • B090LRN0591 ()
  • B090LRN0590 ()
  • B090LRN0592 ()

  • Catheter Working Length: 59 Centimeter
  • Introducer Sheath Compatibility: 7 French
LR-N-059

  • Intravascular occluding balloon catheter, image-guided

XO Cath - B090E20130S0

The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-S
In Commercial Distribution

  • B090E20130S1 ()
  • B090E20130S0 ()
  • B090E20130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-S

  • Vascular microcatheter

XO Cath - B090E20130B0

The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
E20-130-B
In Commercial Distribution

  • B090E20130B1 ()
  • B090E20130B0 ()
  • B090E20130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
E20-130-B

  • Vascular microcatheter

XO Cross 35 - B090C35175H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-175-H
In Commercial Distribution

  • B090C35175H1 ()
  • B090C35175H0 ()
  • B090C35175H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 175 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-175-H

  • Vascular guide-catheter, single-use

XO Cross 35 - B090C35135H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135-H
In Commercial Distribution

  • B090C35135H1 ()
  • B090C35135H0 ()
  • B090C35135H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 135 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-135-H

  • Vascular guide-catheter, single-use

XO Cross 35 - B090C35090H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-090-H
In Commercial Distribution

  • B090C35090H1 ()
  • B090C35090H0 ()
  • B090C35090H2 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 90 Centimeter
  • Introducer Sheath Compatibility: 4 French
  • Crossing Profile: 3.2 French
C35-090-H

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C14175H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175-H
In Commercial Distribution

  • B090C14175H1 ()
  • B090C14175H0 ()
  • B090C14175H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-175-H

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C14135H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-135-H
In Commercial Distribution

  • B090C14135H1 ()
  • B090C14135H0 ()
  • B090C14135H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135-H

  • Vascular guide-catheter, single-use

XO Cross 14 - B090C14090H0

The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090-H
In Commercial Distribution

  • B090C14090H1 ()
  • B090C14090H0 ()
  • B090C14090H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090-H

  • Vascular guide-catheter, single-use

Control 10T Mechanical Thrombectomy System Tubing, Female Suction - B090ASP10400

The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1040
In Commercial Distribution

  • B090ASP10401 ()
  • B090ASP10400 ()
  • B090ASP10402 ()
ASP-1040

  • Thrombectomy tubing set, non-electronic

Control 10T Mechanical Thrombectomy Filter - B090ASP10390

The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.”
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1039
In Commercial Distribution

  • B090ASP10391 ()
  • B090ASP10390 ()
  • B090ASP10392 ()
ASP-1039

  • Thrombectomy tubing set, non-electronic

Control 11F Mechanical Thrombectomy System - B090ASP10360

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1036
In Commercial Distribution

  • B090ASP10361 ()
  • B090ASP10360 ()
  • B090ASP10362 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
ASP-1036

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

Control 7F Mechanical Thrombectomy System - B090ASP10330

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1033
In Commercial Distribution

  • B090ASP10331 ()
  • B090ASP10330 ()
  • B090ASP10332 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 7 French
ASP-1033

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

Control Mechanical Aspirator 30ml - B090ASP10290

The CONTROL MECHANICAL ASPIRATOR is intended to aspirate fluids from the body
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1029
In Commercial Distribution

  • B090ASP10291 ()
  • B090ASP10290 ()
  • B090ASP10292 ()
ASP-1029

  • General-purpose syringe, single-use

Control 11F Mechanical Thrombectomy System - B090ASP10210

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1021
In Commercial Distribution

  • B090ASP10211 ()
  • B090ASP10210 ()
  • B090ASP10212 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
ASP-1021

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

Control 7F Mechanical Thrombectomy System - B090ASP10130

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1013
In Commercial Distribution

  • B090ASP10131 ()
  • B090ASP10130 ()
  • B090ASP10132 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 7 French
ASP-1013

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

Control RX-LP Mechanical Thrombectomy System - B090ASP10010

The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical 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.
ASP-1001
In Commercial Distribution

  • B090ASP10011 ()
  • B090ASP10010 ()
  • B090ASP10012 ()

  • Catheter Gauge: 6 French
  • Catheter Length: 136 Centimeter
ASP-1001

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

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 9F Mechanical Thrombectomy System, 90cm - B090A90900

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A9-090
In Commercial Distribution

  • B090A90901 ()
  • B090A90900 ()
  • B090A90902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 9 French
A9-090

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

Control 9F Mechanical Thrombectomy System, 60cm - B090A90600

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A9-060
In Commercial Distribution

  • B090A90601 ()
  • B090A90600 ()
  • B090A90602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 9 French
A9-060

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

Control 7F Mechanical Thrombectomy System - B090A70900

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A7-090
In Commercial Distribution

  • B090A70901 ()
  • B090A70900 ()
  • B090A70902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 7 French
A7-090

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

Control 7F Mechanical Thrombectomy System - B090A70600

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A7-060
In Commercial Distribution

  • B090A70600 ()
  • B090A70601 ()
  • B090A70602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 7 French
A7-060

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

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 11F Mechanical Thrombectomy System - B090A110900

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A11-090
In Commercial Distribution

  • B090A110901 ()
  • B090A110900 ()
  • B090A110902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
A11-090

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

Control 11F Mechanical Thrombectomy System, 60cm - B090A110600

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A11-060
In Commercial Distribution

  • B090A110601 ()
  • B090A110600 ()
  • B090A110602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
A11-060

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

SPINR - B0905XGW0

Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
5X-GW
In Commercial Distribution

  • B0905XGW1 ()
  • B0905XGW0 ()
  • B0905XGW2 ()
5X-GW

  • Torque manipulation device

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

Knight Microcatheter - B0902P0130S0

The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-S
In Commercial Distribution

  • B0902P0130S1 ()
  • B0902P0130S0 ()
  • B0902P0130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-S

  • Vascular microcatheter

Knight Microcatheter - B0902P0130B0

The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-B
In Commercial Distribution

  • B0902P0130B1 ()
  • B0902P0130B0 ()
  • B0902P0130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-B

  • Vascular microcatheter

InTray® Mueller Hinton Chocolate Agar - B08824830

Mueller Hinton Chocolate Agar is presented in a cassette-like device with individual seal and label for use in qualitative procedures for the isolation and cultivation of fastidious organisms, particularly Haemophilus species. InTray Mueller Hinton Chocolate agar contains beef extract, vitamins and mineral enrichment, acid hydrolysate of casein, cystine, tryptophan, starch, agar and hemoglobin. Agar appears chocolate brown with a final pH of 7.3 ± 0.2 at 25°C.
BIO-MED DIAGNOSTICS, INC.
2483
In Commercial Distribution

  • B08824834 ()
  • B08824830 ()
  • B08824832 ()
22-483-001

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD

InTray® DM - B08820630

An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
BIO-MED DIAGNOSTICS, INC.
2063
In Commercial Distribution

  • B08820630 ()
  • B08820634 ()
  • B08820632 ()
22-063-000

  • Multiple dermatophyte species culture isolate identification IVD, kit
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