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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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Endure - B531ETNC5050

Endotracheal Tube, Standard Type, Cuffed, Size = 5.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC5051217
In Commercial Distribution

  • B531ETNC5052 ()
  • B531ETNC5051 ()
  • B531ETNC5050 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
ETNC505

  • Basic endotracheal tube, single-use

Endure - B531ETNC4550

Endotracheal Tube, Standard Type, Cuffed, Size = 4.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC4551217
In Commercial Distribution

  • B531ETNC4550 ()
  • B531ETNC4551 ()
  • B531ETNC4552 ()

  • Lumen/Inner Diameter: 4.5 Millimeter
ETNC455

  • Basic endotracheal tube, single-use

Endure - B531ETNC4050

Endotracheal Tube, Standard Type, Cuffed, Size = 4.0 mm Inner Diameter.
ENDURE INDUSTRIES
ETNC4051217
In Commercial Distribution

  • B531ETNC4052 ()
  • B531ETNC4051 ()
  • B531ETNC4050 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
ETNC405

  • Basic endotracheal tube, single-use

Endure - B531ES1450

Endotracheal Stylet, Size= 14 Fr, fits endotracheal tubes of sizes internal diameter > 5.5mm.
ENDURE INDUSTRIES
ES1451217
In Commercial Distribution

  • B531ES1452 ()
  • B531ES1451 ()
  • B531ES1450 ()

  • Size- 14 Fr
ES145

  • Artificial airway stylet, single-use

Endure - B531ES1050

Endotracheal Stylet, size= 10Fr, fits endotracheal tubes of sizes internal diameter 4-5 mm.
ENDURE INDUSTRIES
ES1051217
In Commercial Distribution

  • B531ES1052 ()
  • B531ES1051 ()
  • B531ES1050 ()

  • size- 10Fr
ES105

  • Artificial airway stylet, single-use

Colonic Irrigation Kit - B482Z200

Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste segmented hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Segmented Hose / Large Hydrokit
In Commercial Distribution

  • B482Z201 ()
  • B482Z200 ()
  • B482Z202 ()
Z-20

  • Colonic lavage kit, non-surgical

Colonic Irrigation Kit - B482Z160

Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with limiter and Obturator, a water inflow tube, a collapsible waste segmented hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Segmented Hose / Hydrokit with limiter
In Commercial Distribution

  • B482Z161 ()
  • B482Z160 ()
  • B482Z162 ()
Z-16

  • Colonic lavage kit, non-surgical

Colonic irrigation Kit - B482Z100

Colon Hydrotherapy Disposable Single-Use Kit, consisting of a small size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Small Hydrokit
In Commercial Distribution

  • B482Z101 ()
  • B482Z100 ()
  • B482Z102 ()
Z-10

  • Colonic lavage kit, non-surgical

Colonic Irrigation Kit - B482Z090

Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
TRANSCENDENCIAS COMERCIALES SL
Large Hydrokit
In Commercial Distribution

  • B482Z091 ()
  • B482Z090 ()
  • B482Z092 ()
Z-09

  • Colonic lavage kit, non-surgical

Checkpoint Head & Neck - B13093941

Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9394
In Commercial Distribution

  • B13093941 ()
  • B13093942 ()
  • B13093943 ()


  • Nerve-locating system

Checkpoint - B13090941

Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9094
In Commercial Distribution

  • B13090941 ()
  • B13090942 ()
  • B13090943 ()


  • Nerve-locating system

STINGRAY SURGICAL PRODUCTS - B112S048000

Disposable Bipolar Cord Straight 12 FT
STINGRAY SURGICAL PRODUCTS, LLC
S04-800
Not in Commercial Distribution

  • B112S048000 ()
  • B112S048001 ()
  • B112S048002 ()


  • Electrical-only medical device connection cable, single-use

Molded Products, Inc. - B144MPC855S250PP3

Sterile DIN Adapter, Polypropylene, Fits 1/4" ID Tubing
MOLDED PRODUCTS, INC.
MPC-855S.250PP
In Commercial Distribution

  • B144MPC855S250PP5 ()
  • B144MPC855S250PP4 ()
  • B144MPC855S250PP3 ()
  • B144MPC855NS250PP0 ()
MPC-855S.250PP

  • Haemodialysis blood tubing set, single-use

Molded Products, Inc. - B144MPC30000

Sterile Thumb Forcep
MOLDED PRODUCTS, INC.
MPC-3000
In Commercial Distribution

  • B144MPC30002 ()
  • B144MPC30000 ()
  • B144MPC30003 ()
MPC-3000

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use

Molded Products, Inc. - B144MPC1100

NeedleFree Injection Site
MOLDED PRODUCTS, INC.
MPC-110
In Commercial Distribution

  • B144MPC1101 ()
  • B144MPC1100 ()
  • B144MPC1104 ()
MPC-110

  • Catheter injection port

Premium Study Kit - B14360201261

Single use, premium study kit with two XXlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XXLarge
In Commercial Distribution

  • B14360201282 ()
  • B14360201261 ()
  • B14360201272 ()
602-0123

  • Electroencephalograph

Premium Study Kit - B14360201231

Single use, premium study kit with two Xlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XLarge
In Commercial Distribution

  • B14360201252 ()
  • B14360201231 ()
  • B14360201242 ()
602-0123

  • Electroencephalograph

Premium Study Kit - B14360201201

Single use, premium study kit with two large ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - Large
In Commercial Distribution

  • B14360201222 ()
  • B14360201201 ()
  • B14360201212 ()
602-0120

  • Electroencephalograph

Premium Study Kit - B14360201141

Single use, premium study kit extra extra large.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B14360201141 ()
  • B14360201162 ()
  • B14360201152 ()
602-0114

  • Electroencephalograph

Premium Study Kit - B14360201111

Single use, premium study kit extra large.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B14360201111 ()
  • B14360201132 ()
  • B14360201122 ()
602-0111

  • Electroencephalograph

Premium Study Kit - B14360201081

Single use, premium study kit large.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B14360201081 ()
  • B14360201102 ()
  • B14360201092 ()
602-0108

  • Electroencephalograph

Premium Study Kit - B14360200791

Single use, proact premium study kit.
Cleveland Medical Devices Inc.
Proact - Single
In Commercial Distribution

  • B14360200791 ()
  • B14360200812 ()
  • B14360200802 ()
602-0079

  • Electroencephalograph

Study Kit - B14360200761

Single use study kit (compatible with thermistor).
Cleveland Medical Devices Inc.
Compatible with Thermistor - Single
In Commercial Distribution

  • B14360200761 ()
  • B14360200772 ()
  • B14360200782 ()
602-0076

  • Electroencephalograph

Study Kit - B14360200751

No Description
Cleveland Medical Devices Inc.
Single
In Commercial Distribution

  • B14360200751 ()
  • B14360200692 ()
  • B14360200682 ()
602-0075

  • Electroencephalograph

ReadyRip Belt - B143502020450

Single use, extra extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B143502020450 ()
  • B14360201051 ()
  • B14360201021 ()
502-0204-5

  • Electroencephalograph

ReadyRip Belt - B143502020440

Single use, extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B143502020440 ()
  • B14360201041 ()
  • B14360201011 ()
502-0204-4

  • Electroencephalograph

ReadyRip Belt - B143502020430

Single use, large respiratory belt.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B143502020430 ()
  • B14360201031 ()
  • B14360201001 ()
502-0204-3

  • Electroencephalograph

ReadyRip Belt - B143502020420

Single use, medium respiratory belt.
Cleveland Medical Devices Inc.
Medium - Single
In Commercial Distribution

  • B143502020420 ()
  • B14360201311 ()
  • B14360201301 ()
502-0204-2

  • Electroencephalograph

Q-Lase™ Adjustable Sheath - B145115150

Q-Lase Adjustable Sheath
OPTICAL INTEGRITY INC
11515
In Commercial Distribution

  • B145115152 ()
  • B145115151 ()
  • B145115150 ()

  • Outer Diameter: 800 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable

Molded Products, Inc. - B144UM872360

STERILE ACCESS & RETURN LINE SET
MOLDED PRODUCTS, INC.
UM-872-36
In Commercial Distribution

  • B144UM872360 ()
  • B144UM872361 ()
  • B144UM872364 ()
UM-872-36

  • Haemodialysis blood tubing set, single-use
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