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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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Capture - D745701031CAP00240

Heavy Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0024
In Commercial Distribution

  • D745701031CAP00051 ()
  • D745701028CAP00041 ()
  • D745701031CAP00240 ()
70-1031-CAP0024

  • Silicone dental impression material

DCTclock - B626100720

DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

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

  • Drawing-test cognitive function analysis device

DCTclock - B626100030

DCTclock Test Form - Research
Linus Health, Inc.
10003
In Commercial Distribution

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

  • Drawing-test cognitive function analysis device

Lithotomy Drape - B6143511011

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

Gesiva Medical - B598GMMHT0001

No Description
GESIVA MEDICAL LLC
Medium High Tension Ring
In Commercial Distribution

  • B598GMMHT0001 ()
  • B598GMMHT0002 ()
  • B598GMTRK0001 ()


  • Penile vacuum device

Vios Monitoring System Pulse Oximetry Sensor - B595L2050R0

The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. The Vios Chest Sensor and Adapter are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution

  • B595L2050R0 ()
  • B595L2050R1 ()
  • B595L2050R2 ()
L2050R

  • Pulse oximeter probe, reusable
  • Pulse Co-oximeter probe, reusable

Soviflex - B79510010

Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor

SPEAX Patch - B792FGN002

Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system

OLO CBC Test Kit - B787TK10

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
In Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count

JK-RUSA - B5331181200

No Description
BLV Licht- und Vakuumtechnik GmbH
400 R7s
In Commercial Distribution

  • B5331181201 ()
  • B5331181200 ()
  • B5331181202 ()
  • B5331081960 ()
118120

  • Ultraviolet tanning device

Endure - B531YSBVS20

Yankauer Suction Handle, with Bulbous Tip, Vented, Sterile
ENDURE INDUSTRIES
YSBVS21217
In Commercial Distribution

  • B531YSBVS20 ()
  • B531YSBVS21 ()
  • B531YSBVS22 ()
YSBVS2

  • Suction cannula, single-use

Endure - B531YSBNS20

Yankauer Suction Handle, with Bulbous Tip, Non-Vented, Sterile
ENDURE INDUSTRIES
YSBNS21217
In Commercial Distribution

  • B531YSBNS20 ()
  • B531YSBNS21 ()
  • B531YSBNS22 ()
YSBNS2

  • Suction cannula, single-use

Endure - B531NPS2820

Nasopharyngeal Airway, Size = 28 Fr, Internal Diameter 6 inches
ENDURE INDUSTRIES
NPS2821217
In Commercial Distribution

  • B531NPS2820 ()
  • B531NPS2821 ()
  • B531NPS2822 ()
NPS282

  • Nasopharyngeal airway, single-use

Endure - B531ETRC7550

Endotracheal Tube, Reinforced, Cuffed, Size = 7.5 mm Inner Diameter.
ENDURE INDUSTRIES
ETRC7551217
In Commercial Distribution

  • B531ETRC7552 ()
  • B531ETRC7551 ()
  • B531ETRC7550 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
ETRC755

  • Reinforced endotracheal tube, single-use

Endure - B531ETRC7050

Endotracheal Tube, Reinforced Type, Cuffed, Size = 7 mm Inner Diameter.
ENDURE INDUSTRIES
ETRC7051217
In Commercial Distribution

  • B531ETRC7052 ()
  • B531ETRC7051 ()
  • B531ETRC7050 ()

  • Lumen/Inner Diameter: 7 Millimeter
ETRC705

  • Reinforced endotracheal tube, single-use

Endure - B531ETPOU5060

Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 5.0 mm, Sterile
ENDURE INDUSTRIES
ETPOU5061017
In Commercial Distribution

  • B531ETPOU5062 ()
  • B531ETPOU5061 ()
  • B531ETPOU5060 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
ETPOU506

  • Basic endotracheal tube, single-use

Endure - B531ETPOU4560

Endotracheal Tube, Preformed, Oral, Uncuffed, Size 4.5 mm, Sterile
ENDURE INDUSTRIES
ETPOU4561017
In Commercial Distribution

  • B531ETPOU4562 ()
  • B531ETPOU4561 ()
  • B531ETPOU4560 ()

  • Lumen/Inner Diameter: 4.5 Millimeter
ETPOU456

  • Basic endotracheal tube, single-use

Endure - B531ETPOU4060

Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 4.0 mm Internal Diameter, Sterile
ENDURE INDUSTRIES
ETPOU4061017
In Commercial Distribution

  • B531ETPOU4062 ()
  • B531ETPOU4061 ()
  • B531ETPOU4060 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
ETPOU406

  • Basic endotracheal tube, single-use

Endure - B531ETPOU3560

Endotracheal Tube, Preformed, Oral, Uncuffed, Sterile, Size 3.5 mm Internal Diameter
ENDURE INDUSTRIES
ETPOU3561017
In Commercial Distribution

  • B531ETPOU3562 ()
  • B531ETPOU3561 ()
  • B531ETPOU3560 ()

  • Lumen/Inner Diameter: 3.5 Millimeter
ETPOU356

  • Basic endotracheal tube, single-use

Endure - B531ETPOU3060

Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 3.0 mm Internal Diameter, Sterile
ENDURE INDUSTRIES
ETPOU3061017
In Commercial Distribution

  • B531ETPOU3062 ()
  • B531ETPOU3061 ()
  • B531ETPOU3060 ()

  • Lumen/Inner Diameter: 3.0 Millimeter
ETPOU306

  • Basic endotracheal tube, single-use

Endure - B531ETPOC8060

Preformed Endotracheal Tube, Oral, Cuffed, Size = 8.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC8061017
In Commercial Distribution

  • B531ETPOC8062 ()
  • B531ETPOC8061 ()
  • B531ETPOC8060 ()

  • Lumen/Inner Diameter: 8.0 Millimeter
ETPOC806

  • Basic endotracheal tube, single-use

Endure - B531ETPOC7560

Preformed Endotracheal Tube, Oral, Cuffed, Size = 7.5 mm Inner Diameter, Sterile
ENDURE INDUSTRIES
ETPOC7561017
In Commercial Distribution

  • B531ETPOC7562 ()
  • B531ETPOC7561 ()
  • B531ETPOC7560 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
ETPOC756

  • Basic endotracheal tube, single-use

Endure - B531ETPOC7060

Preformed Endotracheal Tube, Oral, Cuffed, Size = 7.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC7061017
In Commercial Distribution

  • B531ETPOC7062 ()
  • B531ETPOC7061 ()
  • B531ETPOC7060 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
ETPOC706

  • Basic endotracheal tube, single-use

Endure - B531ETPOC6560

Preformed Endotracheal Tube, Oral, Cuffed, Size = 6.5 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC6561017
In Commercial Distribution

  • B531ETPOC6562 ()
  • B531ETPOC6561 ()
  • B531ETPOC6560 ()

  • Lumen/Inner Diameter: 6.5 Millimeter
ETPOC656

  • Basic endotracheal tube, single-use

Endure - B531ETPOC6060

Preformed Endotracheal Tube, Oral, Cuffed, Size = 6.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC6061017
In Commercial Distribution

  • B531ETPOC6062 ()
  • B531ETPOC6061 ()
  • B531ETPOC6060 ()

  • Lumen/Inner Diameter: 6.0 Millimeter
ETPOC606

  • Basic endotracheal tube, single-use

Endure - B531ETPOC5060

Preformed Endotracheal Tube, Oral, Cuffed, Size = 5.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC5061017
In Commercial Distribution

  • B531ETPOC5062 ()
  • B531ETPOC5061 ()
  • B531ETPOC5060 ()

  • Lumen/Inner Diameter: 5.0 Millimeter
ETPOC506

  • Basic endotracheal tube, single-use

Endure - B531ETPOC4560

Preformed Endotracheal Tube, Oral, Cuffed, Size = 4.5 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC4561017
In Commercial Distribution

  • B531ETPOC4560 ()
  • B531ETPOC4561 ()
  • B531ETPOC4562 ()

  • Lumen/Inner Diameter: 4.5 Millimeter
ETPOC456

  • Basic endotracheal tube, single-use

Endure - B531ETPOC4060

Preformed Endotracheal Tube, Oral, Cuffed, Size = 4.0 mm Inner Diameter
ENDURE INDUSTRIES
ETPOC4061017
In Commercial Distribution

  • B531ETPOC4062 ()
  • B531ETPOC4061 ()
  • B531ETPOC4060 ()

  • Lumen/Inner Diameter: 4.0 Millimeter
ETPOC406

  • Basic endotracheal tube, single-use

Endure - B531ETPNC7560

Endotracheal Tube, Preformed, Nasal, Cuffed, Size 7.5 mm internal diameter
ENDURE INDUSTRIES
ETPNC7561017
In Commercial Distribution

  • B531ETPNC7562 ()
  • B531ETPNC7561 ()
  • B531ETPNC7560 ()

  • Lumen/Inner Diameter: 7.5 Millimeter
ETPNC756

  • Basic endotracheal tube, single-use

Endure - B531ETPNC7060

Endotracheal Tube, Preformed, Nasal, Cuffed, Size 7.0 mm Internal Diameter, Sterile
ENDURE INDUSTRIES
ETPNC7061017
In Commercial Distribution

  • B531ETPNC7062 ()
  • B531ETPNC7061 ()
  • B531ETPNC7060 ()

  • Lumen/Inner Diameter: 7.0 Millimeter
ETPNC706

  • Basic endotracheal tube, single-use
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