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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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FlexStone Basket - G380FSA120210

Single-Use Steerable Basket
EndoTheia, Inc.
FSA-120-21
In Commercial Distribution

  • G380FSA120210 ()
  • G380FSA120211 ()
  • G380FSA120212 ()


  • Urinary stone retrieval basket, single-use

NDL, RBN-132 - M9797405005M0

NDL, RBN-132, STERILE, F/G
RANFAC CORP.
13 GAUGE x 2"
In Commercial Distribution

  • M9797405005M9 ()
  • M9797405005M1 ()
  • M9797405005M0 ()

  • Needle Gauge: 13 Gauge
  • Length: 2 Inch
RBN-132

  • Bone marrow biopsy needle, single-use

NDL, RBN-114, STERILE, F/G - M9797405001M0

NDL, RBN-114, STERILE, F/G PN 74050-01M
RANFAC CORP.
11 GAUGE x 4"
In Commercial Distribution

  • M9797405001M9 ()
  • M9797405001M1 ()
  • M9797405001M0 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
RBN-114

  • Bone marrow biopsy needle, single-use

CorNeat EverPatch - G16010362950

Permanent Tissue-Integrating Surgical Matrix
CORNEAT VISION LTD
1007691
In Commercial Distribution

  • G16010362951 ()
  • G16010362950 ()
  • G16010362952 ()

  • 5.0 mm X 6.5 mm X 100 um
1036295

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

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 (NIBP) continuously 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 non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment. VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions. The VMS Adapter and Chest Sensor 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

RTC 26-C Inline Aerosol Adapter - M996RTC26C0

The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing. The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 26-C
In Commercial Distribution

  • M996RTC26C5 ()
  • M996RTC26C0 ()
  • M996RTC26C4 ()
RTC 26-C

  • Metered dose inhaler
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