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

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

  • Outer Diameter: 3 Millimeter
TIVH30

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

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

  • Outer Diameter: 2 Micrometer
TIVH20

  • Valvulotome, percutaneous
Tru-Fix Catheter Fixation Kit - 16F
URESIL, LLC
TFK-16
In Commercial Distribution

  • H862TFK162 ()
  • H862TFK161 ()
  • H862TFK160 ()

  • Catheter Gauge: 16 French
TFK-16

  • Wearable percutaneous catheter/tube holder
Tru-Fix Catheter Fixation Kit - 14F
URESIL, LLC
TFK-14
In Commercial Distribution

  • H862TFK142 ()
  • H862TFK141 ()
  • H862TFK140 ()

  • Catheter Gauge: 14 French
TFK-14

  • Wearable percutaneous catheter/tube holder
Tru-Fix Catheter Fixation Kit - 8F
URESIL, LLC
TFK-08
In Commercial Distribution

  • H862TFK082 ()
  • H862TFK081 ()
  • H862TFK080 ()

  • Catheter Gauge: 8 French
TFK-08

  • Wearable percutaneous catheter/tube holder
Tru-Fix Fixation Dressing Replacement
URESIL, LLC
TFD-R
In Commercial Distribution

  • H862TFDR2 ()
  • H862TFDR1 ()
  • H862TFDR0 ()
TFD-R

  • Wearable percutaneous catheter/tube holder
Tru-Close Suction Drainage System - 500ml - "D" port
URESIL, LLC
TCS500D
In Commercial Distribution

  • H862TCS500D2 ()
  • H862TCS500D1 ()
  • H862TCS500D0 ()

  • Total Volume: 500 Milliliter
TCS500D

  • Closed-wound/centesis drainage receptacle
Tru-Close Suction Drainage System - 500ml
URESIL, LLC
TCS500
In Commercial Distribution

  • H862TCS5002 ()
  • H862TCS5001 ()
  • H862TCS5000 ()

  • Total Volume: 500 Milliliter
TCS500

  • Closed-wound/centesis drainage receptacle
Tru-Close Suction Drainage System - 1000ml
URESIL, LLC
TCS1000
In Commercial Distribution

  • H862TCS10002 ()
  • H862TCS10001 ()
  • H862TCS10000 ()

  • Total Volume: 1000 Milliliter
TCS1000

  • Closed-wound/centesis drainage receptacle
Posi-Stick Intro. Set w/PT Marker & .038" Super-Stiff GW
URESIL, LLC
PS2-38SW
Not in Commercial Distribution

  • H862PS238SW2 ()
  • H862PS238SW1 ()
  • H862PS238SW0 ()

  • Outer Diameter: 0.038 Inch
PS2-38SW

  • Fascial tissue dilator, single-use
Posi-Stick Intro. Set w/PT Marker & .035" Super-Stiff GW
URESIL, LLC
PS2-35SW
Not in Commercial Distribution

  • H862PS235SW2 ()
  • H862PS235SW1 ()
  • H862PS235SW0 ()

  • Outer Diameter: 0.035 Inch
PS2-35SW

  • Fascial tissue dilator, single-use
Posi-Stick .018" (.046mm) Guidewire
URESIL, LLC
PS2-18
Not in Commercial Distribution

  • H862PS2182 ()
  • H862PS2181 ()
  • H862PS2180 ()

  • Outer Diameter: 0.018 Inch
PS2-18

  • Peripheral vascular guidewire, manual
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
URESIL, LLC
NSL2T-1028H
Not in Commercial Distribution

  • H862NSL2T1028H1 ()
  • H862NSL2T1028H0 ()
  • H862NSL2T1028H2 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NSL2T-1028H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 26 cm Pig-to-Pig
URESIL, LLC
NSL2T-1026H
Not in Commercial Distribution

  • H862NSL2T1026H1 ()
  • H862NSL2T1026H0 ()
  • H862NSL2T1026H2 ()

  • Catheter Gauge: 10 French
  • Length: 26 Centimeter
NSL2T-1026H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 22 cm Pig-to-Pig
URESIL, LLC
NSL2T-1022H
Not in Commercial Distribution

  • H862NSL2T1022H1 ()
  • H862NSL2T1022H0 ()
  • H862NSL2T1022H2 ()

  • Catheter Gauge: 10 French
  • Length: 22 Centimeter
NSL2T-1022H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
URESIL, LLC
NSL2T-0828H
Not in Commercial Distribution

  • H862NSL2T0828H1 ()
  • H862NSL2T0828H0 ()
  • H862NSL2T0828H2 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NSL2T-0828H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 22 cm Pig-to-Pig
URESIL, LLC
NSL2T-0822H
Not in Commercial Distribution

  • H862NSL2T0822H1 ()
  • H862NSL2T0822H0 ()
  • H862NSL2T0822H2 ()

  • Catheter Gauge: 8 French
  • Length: 22 Centimeter
NSL2T-0822H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 28 cm Pig-to-Pig
URESIL, LLC
NSL2-1028H
In Commercial Distribution

  • H862NSL21028H2 ()
  • H862NSL21028H1 ()
  • H862NSL21028H0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NSL2-1028H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 10F, 24 cm Pig-to-Pig
URESIL, LLC
NSL2-1024H
In Commercial Distribution

  • H862NSL21024H2 ()
  • H862NSL21024H1 ()
  • H862NSL21024H0 ()

  • Catheter Gauge: 10 French
  • Length: 24 Centimeter
NSL2-1024H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 28 cm Pig-to-Pig
URESIL, LLC
NSL2-0828H
In Commercial Distribution

  • H862NSL20828H2 ()
  • H862NSL20828H1 ()
  • H862NSL20828H0 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NSL2-0828H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
URESIL, LLC
NSL2-0824H
In Commercial Distribution

  • H862NSL20824H2 ()
  • H862NSL20824H1 ()
  • H862NSL20824H0 ()

  • Catheter Gauge: 8 French
  • Length: 24 Centimeter
NSL2-0824H

  • Nephrostomy catheter
Nephrostomy "HB" Catheter - Non-Locking - 10F 35
URESIL, LLC
NCP-1035HB
Not in Commercial Distribution

  • H862NCP1035HB2 ()
  • H862NCP1035HB1 ()
  • H862NCP1035HB0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCP-1035HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 14F
URESIL, LLC
NCL2T-1450HB
Not in Commercial Distribution

  • H862NCL2T1450HB1 ()
  • H862NCL2T1450HB0 ()
  • H862NCL2T1450HB2 ()

  • Catheter Gauge: 14 French
  • Length: 40 Centimeter
NCL2T-1450HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, 14F
URESIL, LLC
NCL2T-1435H
Not in Commercial Distribution

  • H862NCL2T1435H1 ()
  • H862NCL2T1435H0 ()
  • H862NCL2T1435H2 ()

  • Catheter Gauge: 14 French
  • Length: 28 Centimeter
NCL2T-1435H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 10F
URESIL, LLC
NCL2T-1050HB
Not in Commercial Distribution

  • H862NCL2T1050HB1 ()
  • H862NCL2T1050HB0 ()
  • H862NCL2T1050HB2 ()

  • Catheter Gauge: 10 French
  • Length: 41 Centimeter
NCL2T-1050HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, 10F
URESIL, LLC
NCL2T-1035H
Not in Commercial Distribution

  • H862NCL2T1035H1 ()
  • H862NCL2T1035H0 ()
  • H862NCL2T1035H2 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCL2T-1035H

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 14F
URESIL, LLC
NCL2-1450HB
In Commercial Distribution

  • H862NCL21450HB2 ()
  • H862NCL21450HB1 ()
  • H862NCL21450HB0 ()

  • Catheter Gauge: 14 French
  • Length: 40 Centimeter
NCL2-1450HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 14F
URESIL, LLC
NCL2-1435HB
In Commercial Distribution

  • H862NCL21435HB2 ()
  • H862NCL21435HB1 ()
  • H862NCL21435HB0 ()

  • Catheter Gauge: 14 French
  • Length: 28 Centimeter
NCL2-1435HB

  • Nephrostomy catheter
HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 12F
URESIL, LLC
NCL2-1235HB
In Commercial Distribution

  • H862NCL21235HB2 ()
  • H862NCL21235HB1 ()
  • H862NCL21235HB0 ()

  • Catheter Gauge: 12 French
  • Length: 27 Centimeter
NCL2-1235HB

  • Nephrostomy catheter
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