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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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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
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
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
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
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
HR Wide angle lens Consultation
PHAKOS
MV LV 41 HR
In Commercial Distribution

  • B564MVLV41HR2 ()
  • B564MVLV41HR0 ()
  • B564MVLV41HR4 ()
MV LV 41 HR

  • Vitrectomy contact lens, single-use
Disposable Retinal Cryo Probe
PHAKOS
MV CY 100
In Commercial Distribution

  • B564MVCY1000 ()
  • B564MVCY1002 ()
  • B564MVCY1004 ()
MV CY 100

  • General cryosurgical system, cryogen gas, mechanical
DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

  • B626100722 ()
  • B626100721 ()
  • B626100720 ()
10072

  • Drawing-test cognitive function analysis device
DCTclock Test Form - Research
Linus Health, Inc.
10003
In Commercial Distribution

  • B626100030 ()
  • B626100031 ()
  • B626100032 ()
10003

  • Drawing-test cognitive function analysis device
The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
PROCEPT BIOROBOTICS CORPORATION
351101
In Commercial Distribution

  • B6143511011 ()
  • B6143511018 ()
  • B6143511012 ()
351101

  • Patient surgical drape, single-use
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