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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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Barrier - H816BB0312H1

3 x 12 instrument / equipment drape, chair sox
CERTOL INTERNATIONAL, LLC
BB-0312H
In Commercial Distribution

  • H816BB0312H2 ()
  • H816BB0312H1 ()
  • H816BB0312H0 ()
BB-0312H-1

  • Instrument/equipment drape, single-use, non-sterile

VenaCure EVLT - H787EVLTPVAKUS0

VenaCure 400 Micron Perforator and Accessory Vein Ablation Kit
ANGIODYNAMICS, INC.
EVLTPVAKUS
In Commercial Distribution

  • H787EVLTPVAKUS0 ()
  • H787EVLTPVAKUS5 ()

  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLTPVAK0

VenaCure 400 Micron Fiber Procedure Kit
ANGIODYNAMICS, INC.
EVLT/PVAK
In Commercial Distribution

  • H787EVLTPVAK0 ()
  • H787EVLTPVAK5 ()

  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLT80OPS0

VenaCure 80cm Procedure Kit w/ Spotlight OPS Sheath
ANGIODYNAMICS, INC.
EVLT/80-OPS
In Commercial Distribution

  • H787EVLT80OPS0 ()
  • H787EVLT80OPS5 ()

  • Catheter Gauge: 4 French
  • Length: 80 Centimeter
  • Outer Diameter: 1.2 Millimeter
  • Needle Gauge: 19 Gauge


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLT55OPS0

VenaCure 55cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector
ANGIODYNAMICS, INC.
EVLT/55-OPS
In Commercial Distribution

  • H787EVLT55OPS0 ()
  • H787EVLT55OPS5 ()

  • Needle Gauge: 19 Gauge
  • Outer Diameter: 1.2 Millimeter
  • Length: 55 Centimeter
  • Catheter Gauge: 4 French


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLT25OPS0

VenaCure 25cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector
ANGIODYNAMICS, INC.
EVLT/25-OPS
In Commercial Distribution

  • H787EVLT25OPS0 ()
  • H787EVLT25OPS5 ()

  • Needle Gauge: 19 Gauge
  • Length: 25 Centimeter
  • Catheter Gauge: 4 French
  • Outer Diameter: 1.2 Millimeter


  • Varicose vein lasing procedure kit

ENVI - H965355200

NEEDLE 18G X 15 CHIBA STYLET ECHO TIP GUIDEWIRE, 0.035 X 150CM
NAVILYST MEDICAL, INC.
35-520
In Commercial Distribution

  • H965355200 ()
  • H965355201 ()
  • 15051684023733 ()

  • Lumen/Inner Diameter: 0.95 Millimeter
  • Needle Gauge: 18 Gauge
  • Length: 15 Centimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355190

NEEDLE 18G X 15 CHIBA STYLET ECHO TIP
NAVILYST MEDICAL, INC.
35-519
In Commercial Distribution

  • H965355190 ()
  • H965355191 ()
  • 15051684023726 ()

  • Needle Gauge: 18 Gauge
  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 0.95 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355180

NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 150 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-518
In Commercial Distribution

  • H965355180 ()
  • H965355181 ()
  • 15051684023719 ()

  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Catheter Gauge: 6 French
  • Length: 20 Centimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355170

NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 80 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-517
In Commercial Distribution

  • H965355170 ()
  • H965355171 ()
  • 15051684023702 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355160

NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 150 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-516
In Commercial Distribution

  • H965355160 ()
  • H965355161 ()
  • 15051684023696 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355150

NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-515
In Commercial Distribution

  • H965355150 ()
  • H965355151 ()
  • 15051684023689 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Catheter Gauge: 6 French
  • Length: 20 Centimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355140

NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 150 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-514
In Commercial Distribution

  • H965355140 ()
  • H965355141 ()
  • 15051684023672 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355130

NVI MINI STICK 6F X 20CM .018 Ni/Tu .035 X 80 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-513
In Commercial Distribution

  • H965355130 ()
  • H965355131 ()
  • 15051684023665 ()

  • Length: 20 Centimeter
  • Needle Gauge: 21 Gauge
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355120

NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 150 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-512
In Commercial Distribution

  • H965355120 ()
  • H965355121 ()
  • 15051684023658 ()

  • Length: 20 Centimeter
  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge
  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable

ENVI - H965355110

NVI MINI STICK 6F X 20CM .018 Ni/Tu .038 X 80 ROSEN-PTFE
NAVILYST MEDICAL, INC.
35-510
In Commercial Distribution

  • H965355110 ()
  • H965355111 ()
  • 15051684023641 ()

  • Lumen/Inner Diameter: 0.5 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 20 Centimeter
  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable

Exodus - H965105900

Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10590
In Commercial Distribution

  • H965105901 ()
  • H965105900 ()
  • 15051684022866 ()

  • Length: 35 Centimeter
  • Outer Diameter: 2.7 Millimeter
  • Catheter Gauge: 8 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105810

Array Multipurpose Drainage Catheter 10F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10580
In Commercial Distribution

  • H965105811 ()
  • H965105810 ()
  • 15051684022859 ()

  • Length: 35 Centimeter
  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105800

Array Multipurpose Drainage Catheter 8F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10580
In Commercial Distribution

  • H965105801 ()
  • H965105800 ()
  • 15051684022842 ()

  • Catheter Gauge: 8 French
  • Length: 35 Centimeter
  • Outer Diameter: 2.7 Millimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105720

Array Multipurpose Drainage Catheter 14F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10572
In Commercial Distribution

  • H965105721 ()
  • H965105720 ()
  • 15051684022835 ()

  • Length: 35 Centimeter
  • Outer Diameter: 4.7 Millimeter
  • Catheter Gauge: 14 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105710

Array Multipurpose Drainage Catheter 10F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10571
In Commercial Distribution

  • H965105711 ()
  • H965105710 ()
  • 15051684022828 ()

  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French
  • Length: 35 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105620

Array Multipurpose Drainage Catheter 14F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10562
In Commercial Distribution

  • H965105621 ()
  • H965105620 ()
  • 15051684022811 ()

  • Outer Diameter: 4.7 Millimeter
  • Length: 25 Centimeter
  • Catheter Gauge: 14 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105500

Array Multipurpose Drainage Catheter 8F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10550
In Commercial Distribution

  • H965105501 ()
  • H965105500 ()
  • 15051684022804 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105410

Array Multipurpose Drainage Catheter 10F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10541
In Commercial Distribution

  • H965105411 ()
  • H965105410 ()
  • 15051684022798 ()

  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105400

Array Multipurpose Drainage Catheter 8F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10540
In Commercial Distribution

  • H965105401 ()
  • H965105400 ()
  • 15051684022781 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 25 Centimeter
  • Catheter Gauge: 8 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105320

Array Multipurpose Drainage Catheter 12F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10532
In Commercial Distribution

  • H965105321 ()
  • H965105320 ()
  • 15051684022774 ()

  • Catheter Gauge: 12 French
  • Outer Diameter: 4 Millimeter
  • Length: 35 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105310

Array Multipurpose Drainage Catheter 10F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10531
In Commercial Distribution

  • H965105311 ()
  • H965105310 ()
  • 15051684022767 ()

  • Catheter Gauge: 10 French
  • Outer Diameter: 3.4 Millimeter
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105300

Array Multipurpose Drainage Catheter 6F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10530
In Commercial Distribution

  • H965105301 ()
  • H965105300 ()
  • 15051684022750 ()

  • Length: 25 Centimeter
  • Outer Diameter: 2.1 Millimeter
  • Catheter Gauge: 6 French


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105290

Nuance Nephrostomy Drainage Catheter 12F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10529
In Commercial Distribution

  • H965105291 ()
  • H965105290 ()
  • 15051684022743 ()

  • Outer Diameter: 4 Millimeter
  • Catheter Gauge: 12 French
  • Length: 35 Centimeter


  • Nephrostomy catheter

Exodus - H965105280

Believe Biliary Drainage Catheter 14F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10528
In Commercial Distribution

  • H965105281 ()
  • H965105280 ()
  • 15051684022736 ()

  • Catheter Gauge: 14 French
  • Length: 35 Centimeter
  • Outer Diameter: 4.7 Millimeter


  • Biliary drain

Exodus - H965105270

Believe Biliary Drainage Catheter 12F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10527
In Commercial Distribution

  • H965105271 ()
  • H965105270 ()
  • 15051684022729 ()

  • Outer Diameter: 4 Millimeter
  • Length: 35 Centimeter
  • Catheter Gauge: 12 French


  • Biliary drain

Exodus - H965105260

Believe Biliary Drainage Catheter 10F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10526
In Commercial Distribution

  • H965105261 ()
  • H965105260 ()
  • 15051684022712 ()

  • Outer Diameter: 3.4 Millimeter
  • Length: 35 Centimeter
  • Catheter Gauge: 10 French


  • Biliary drain

Exodus - H965105250

Believe Biliary Drainage Catheter 8F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10525
In Commercial Distribution

  • H965105251 ()
  • H965105250 ()
  • 15051684022705 ()

  • Outer Diameter: 2.7 Millimeter
  • Catheter Gauge: 8 French
  • Length: 35 Centimeter


  • Biliary drain

Exodus - H965105240

Nuance Nephrostomy Drainage Catheter 14F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10524
In Commercial Distribution

  • H965105241 ()
  • H965105240 ()
  • 15051684022699 ()

  • Catheter Gauge: 14 French
  • Length: 35 Centimeter
  • Outer Diameter: 4.7 Millimeter


  • Nephrostomy catheter

Exodus - H965105220

Array Multipurpose Drainage Catheter 12F x 25cm with Standard Pigtail
NAVILYST MEDICAL, INC.
10522
In Commercial Distribution

  • H965105221 ()
  • H965105220 ()
  • 15051684022682 ()

  • Catheter Gauge: 12 French
  • Outer Diameter: 4 Millimeter
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105210

Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10521
In Commercial Distribution

  • H965105211 ()
  • H965105210 ()
  • 15051684022675 ()

  • Length: 35 Centimeter
  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105200

Array Multipurpose Drainage Catheter 6F x 15cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10520
In Commercial Distribution

  • H965105201 ()
  • H965105200 ()
  • 15051684022668 ()

  • Outer Diameter: 2.1 Millimeter
  • Catheter Gauge: 6 French
  • Length: 15 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965105180

Nuance Nephrostomy Drainage Catheter 10F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10518
In Commercial Distribution

  • H965105181 ()
  • H965105180 ()
  • 15051684022651 ()

  • Length: 25 Centimeter
  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French


  • Nephrostomy catheter

Exodus - H965105160

Nuance Nephrostomy Drainage Catheter 8F x 35cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10516
In Commercial Distribution

  • H965105161 ()
  • H965105160 ()
  • 15051684022644 ()

  • Catheter Gauge: 8 French
  • Length: 35 Centimeter
  • Outer Diameter: 2.7 Millimeter


  • Nephrostomy catheter

Exodus - H965105140

Nuance Nephrostomy Drainage Catheter 6F x 25cm with Tight Pigtail
NAVILYST MEDICAL, INC.
10514
In Commercial Distribution

  • H965105141 ()
  • H965105140 ()
  • 15051684022637 ()

  • Catheter Gauge: 6 French
  • Length: 25 Centimeter
  • Outer Diameter: 2.1 Millimeter


  • Nephrostomy catheter
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