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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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Chole-Cath Biliary Drainage Catheter - H862CCL2T1650HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
URESIL, LLC
CCL2T-1650HB
Not in Commercial Distribution

  • H862CCL2T1650HB1 ()
  • H862CCL2T1650HB0 ()
  • H862CCL2T1650HB2 ()

  • Catheter Gauge: 16 French
  • Length: 40 Centimeter
CCL2T-1650HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL2T1450HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
URESIL, LLC
CCL2T-1450HB
Not in Commercial Distribution

  • H862CCL2T1450HB1 ()
  • H862CCL2T1450HB0 ()
  • H862CCL2T1450HB2 ()

  • Catheter Gauge: 14 French
  • Length: 40 Centimeter
CCL2T-1450HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL2T1250HBX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 12F
URESIL, LLC
CCL2T-1250HBX
Not in Commercial Distribution

  • H862CCL2T1250HBX1 ()
  • H862CCL2T1250HBX0 ()
  • H862CCL2T1250HBX2 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
CCL2T-1250HBX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL2T1250HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
URESIL, LLC
CCL2T-1250HB
Not in Commercial Distribution

  • H862CCL2T1250HB1 ()
  • H862CCL2T1250HB0 ()
  • H862CCL2T1250HB2 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
CCL2T-1250HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL2T1050HBX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 10F
URESIL, LLC
CCL2T-1050HBX
In Commercial Distribution

  • H862CCL2T1050HBX1 ()
  • H862CCL2T1050HBX0 ()
  • H862CCL2T1050HBX2 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2T-1050HBX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL2T1050HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
URESIL, LLC
CCL2T-1050HB
Not in Commercial Distribution

  • H862CCL2T1050HB1 ()
  • H862CCL2T1050HB0 ()
  • H862CCL2T1050HB2 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2T-1050HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL2T0850HBX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 8F
URESIL, LLC
CCL2T-0850HBX
Not in Commercial Distribution

  • H862CCL2T0850HBX1 ()
  • H862CCL2T0850HBX0 ()
  • H862CCL2T0850HBX2 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2T-0850HBX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL2T0850HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
URESIL, LLC
CCL2T-0850HB
Not in Commercial Distribution

  • H862CCL2T0850HB1 ()
  • H862CCL2T0850HB0 ()
  • H862CCL2T0850HB2 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2T-0850HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21650HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 16F
URESIL, LLC
CCL2-1650HB
In Commercial Distribution

  • H862CCL21650HB2 ()
  • H862CCL21650HB1 ()
  • H862CCL21650HB0 ()

  • Catheter Gauge: 16 French
  • Length: 40 Centimeter
CCL2-1650HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21450HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 14F
URESIL, LLC
CCL2-1450HB
In Commercial Distribution

  • H862CCL21450HB2 ()
  • H862CCL21450HB1 ()
  • H862CCL21450HB0 ()

  • Catheter Gauge: 14 French
  • Length: 40 Centimeter
CCL2-1450HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21450H0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 14F
URESIL, LLC
CCL2-1450H
Not in Commercial Distribution

  • H862CCL21450H2 ()
  • H862CCL21450H1 ()
  • H862CCL21450H0 ()

  • Catheter Gauge: 14 French
  • Length: 40 Centimeter
CCL2-1450H

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21250HX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 12F
URESIL, LLC
CCL2-1250HX
Not in Commercial Distribution

  • H862CCL21250HX2 ()
  • H862CCL21250HX1 ()
  • H862CCL21250HX0 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
CCL2-1250HX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21250HBX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 12F
URESIL, LLC
CCL2-1250HBX
In Commercial Distribution

  • H862CCL21250HBX2 ()
  • H862CCL21250HBX1 ()
  • H862CCL21250HBX0 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
CCL2-1250HBX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21250HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 12F
URESIL, LLC
CCL2-1250HB
In Commercial Distribution

  • H862CCL21250HB2 ()
  • H862CCL21250HB1 ()
  • H862CCL21250HB0 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
CCL2-1250HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21250H0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 12F
URESIL, LLC
CCL2-1250H
Not in Commercial Distribution

  • H862CCL21250H2 ()
  • H862CCL21250H1 ()
  • H862CCL21250H0 ()

  • Catheter Gauge: 12 French
  • Length: 40 Centimeter
CCL2-1250H

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21050HX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 10F
URESIL, LLC
CCL2-1050HX
Not in Commercial Distribution

  • H862CCL21050HX2 ()
  • H862CCL21050HX1 ()
  • H862CCL21050HX0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2-1050HX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21050HBX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 10F
URESIL, LLC
CCL2-1050HBX
Not in Commercial Distribution

  • H862CCL21050HBX2 ()
  • H862CCL21050HBX1 ()
  • H862CCL21050HBX0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2-1050HBX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21050HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 10F
URESIL, LLC
CCL2-1050HB
In Commercial Distribution

  • H862CCL21050HB2 ()
  • H862CCL21050HB1 ()
  • H862CCL21050HB0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2-1050HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL21050H0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 10F
URESIL, LLC
CCL2-1050H
Not in Commercial Distribution

  • H862CCL21050H2 ()
  • H862CCL21050H1 ()
  • H862CCL21050H0 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
CCL2-1050H

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL20850HX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND EXTRA HOLES, 8F
URESIL, LLC
CCL2-0850HX
Not in Commercial Distribution

  • H862CCL20850HX2 ()
  • H862CCL20850HX1 ()
  • H862CCL20850HX0 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2-0850HX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL20850HBX0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, DEPTH MARKS, AND EXTRA HOLES, 8F
URESIL, LLC
CCL2-0850HBX
In Commercial Distribution

  • H862CCL20850HBX2 ()
  • H862CCL20850HBX1 ()
  • H862CCL20850HBX0 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2-0850HBX

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL20850HB0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER AND DEPTH MARKS, 8F
URESIL, LLC
CCL2-0850HB
In Commercial Distribution

  • H862CCL20850HB2 ()
  • H862CCL20850HB1 ()
  • H862CCL20850HB0 ()

  • Catheter Gauge: 8 French
  • Length: 41 Centimeter
CCL2-0850HB

  • Biliary drain

Chole-Cath Biliary Drainage Catheter - H862CCL20850H0

HYDROPHILIC COATED BILIARY LOCKING CATHETER WITH RADIOPAQUE MARKER, 8F
URESIL, LLC
CCL2-0850H
Not in Commercial Distribution

  • H862CCL20850H2 ()
  • H862CCL20850H1 ()
  • H862CCL20850H0 ()

  • Length: 41 Centimeter
  • Catheter Gauge: 8 French
CCL2-0850H

  • Biliary drain

Aspiration and Flush Assembly - H862AFALL0

ASPIRATION FLUSH ADAPTER – LUER LOCK SYSTEM
URESIL, LLC
AFA-LL
In Commercial Distribution

  • H862AFALL2 ()
  • H862AFALL1 ()
  • H862AFALL0 ()
AFA-LL

  • Luer/Luer linear connector, single-use

Aspiration and Flush Assembly - H862AFALB0

ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM
URESIL, LLC
AFA-LB
In Commercial Distribution

  • H862AFALB2 ()
  • H862AFALB1 ()
  • H862AFALB0 ()
AFA-LB

  • Luer/non-ISO80369-standardized linear connector, single-use

Aspiration and Flush Assembly - H862AFA20P0

ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM WITH FUNNEL
URESIL, LLC
AFA-20P
Not in Commercial Distribution

  • H862AFA20P2 ()
  • H862AFA20P1 ()
  • H862AFA20P0 ()
AFA-20P

  • Luer/non-ISO80369-standardized linear connector, single-use

Thora-Vent Thoracic Vent - H862TVST0

THORA-VENT Suction Tubing Set
URESIL, LLC
TVST
In Commercial Distribution

  • H862TVST2 ()
  • H862TVST1 ()
  • H862TVST0 ()
TVST

  • Pneumothorax catheter insertion set

Thora-Vent Thoracic Vent - H862TVOCP0

Thoracic Vent Occlusion Plug
URESIL, LLC
TVOCP
In Commercial Distribution

  • H862TVOCP2 ()
  • H862TVOCP1 ()
  • H862TVOCP0 ()
TVOCP

  • Pneumothorax catheter insertion set

Thora-Vent Thoracic Vent - H862TV13130

THORA-VENT Procedure Tray - 13F 13cm
URESIL, LLC
TV13-13
In Commercial Distribution

  • H862TV13132 ()
  • H862TV13131 ()
  • H862TV13130 ()

  • Catheter Gauge: 13 French
  • Length: 13 Centimeter
TV13-13

  • Pneumothorax catheter insertion set

Thora-Vent Thoracic Vent - H862TV13100

THORA-VENT Procedure Tray - 13F 10cm
URESIL, LLC
TV13-10
In Commercial Distribution

  • H862TV13102 ()
  • H862TV13101 ()
  • H862TV13100 ()

  • Catheter Gauge: 13 French
  • Length: 10 Centimeter
TV13-10

  • Pneumothorax catheter insertion set

Thora-Vent Thoracic Vent - H862TV11130

THORA-VENT Procedure Tray - 11F 13cm
URESIL, LLC
TV11-13
In Commercial Distribution

  • H862TV11132 ()
  • H862TV11131 ()
  • H862TV11130 ()

  • Catheter Gauge: 11 French
  • Length: 13 Centimeter
TV11-13

  • Pneumothorax catheter insertion set

Thora-Vent Thoracic Vent - H862TV11100

THORA-VENT Procedure Tray - 11F 10cm
URESIL, LLC
TV11-10
In Commercial Distribution

  • H862TV11102 ()
  • H862TV11101 ()
  • H862TV11100 ()

  • Catheter Gauge: 11 French
  • Length: 10 Centimeter
TV11-10

  • Pneumothorax catheter insertion set

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK2030NC0

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK2030NC2 ()
  • H862TIVK2030NC1 ()
  • H862TIVK2030NC0 ()

  • Length: 94 Centimeter
TIVK2030

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVK20300

Tru-Incise Valvulotome
URESIL, LLC
TIVK2030
Not in Commercial Distribution

  • H862TIVK20302 ()
  • H862TIVK20301 ()
  • H862TIVK20300 ()

  • Length: 94 Centimeter
TIVK2030

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH40NC0

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH40NC2 ()
  • H862TIVH40NC1 ()
  • H862TIVH40NC0 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH400

Tru-Incise 4mm Cutting Head
URESIL, LLC
TIVH40
Not in Commercial Distribution

  • H862TIVH402 ()
  • H862TIVH401 ()
  • H862TIVH400 ()

  • Outer Diameter: 4 Millimeter
TIVH40

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH30NC0

Tru-Incise 3mm Cutting Head
URESIL, LLC
TIVH30
Not in Commercial Distribution

  • H862TIVH30NC2 ()
  • H862TIVH30NC1 ()
  • H862TIVH30NC0 ()

  • Outer Diameter: 3 Millimeter
TIVH30

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH20NC0

Tru-Incise 2mm Cutting Head
URESIL, LLC
TIVH20
Not in Commercial Distribution

  • H862TIVH20NC2 ()
  • H862TIVH20NC1 ()
  • H862TIVH20NC0 ()

  • Outer Diameter: 2 Micrometer
TIVH20

  • Valvulotome, percutaneous

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH200

Tru-Incise 2mm Cutting Head
URESIL, LLC
TIVH20
Not in Commercial Distribution

  • H862TIVH202 ()
  • H862TIVH201 ()
  • H862TIVH200 ()

  • Outer Diameter: 2 Micrometer
TIVH20

  • Vein stripper, single-use

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVCNC0

Tru-Incise Valvulotome Catheter Kit
URESIL, LLC
TIVC
Not in Commercial Distribution

  • H862TIVCNC2 ()
  • H862TIVCNC1 ()
  • H862TIVCNC0 ()

  • Length: 94 Centimeter
TIVC

  • Valvulotome, percutaneous
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