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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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Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X7
In Commercial Distribution

  • 06972480913030 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X6
In Commercial Distribution

  • 06972480913023 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X2
In Commercial Distribution

  • 06972480913009 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Jiangxi Aicare Medical Technology Co., Ltd.
X1
In Commercial Distribution

  • 06972480912996 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine. The xReader System detects drug classes at the following cutoff concentrations: Amphetamines at 500 ng/mL; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCup may consist of any combination of the listed drug analytes. The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually.
ESCREEN, INC.
BS-0610S
In Commercial Distribution

  • 00867802000290 ()
301

  • Photometric/spectroscopic immunoassay analyser IVD
Single channel dosimeter according to IEC 61674, designed for quality checks at radiographic, fluoroscopic, dental and mammographic X-ray units.
IBA Dosimetry GmbH
VD0201748
In Commercial Distribution

  • EIBAVD02017480 ()
VD0201748

  • Diagnostic x-ray system quality assurance device
skillern sinus probe, malleable, w/ cm graduations at 5.0 cm, 7.0 cm & 9.0 cm, 6 1/2" (16.5 cm)
NOVO SURGICAL, INC.
E1024-11
In Commercial Distribution

  • 00842331162848 ()
E1024-11

  • Mastoid gauge
Cooley Anastomosis Clamp, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 6.0 mm jaw depth, standard pattern
NOVO SURGICAL, INC.
5560-09
Not in Commercial Distribution

  • 00842331116940 ()

  • Length: 16.5 Centimeter
5560-09

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Beck Vascular Clamp, cooley jaws calibrated at 5.0 mm intervals, straight shanks, 6" (15.0 cm), large jaw, medium curve
NOVO SURGICAL, INC.
5550-37
Not in Commercial Distribution

  • 00842331116148 ()

  • Length: 15 Centimeter
5550-37

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Beck Vascular Clamp, cooley jaws calibrated at 5.0 mm intervals, straight shanks, 6" (15.0 cm), small jaw, heavy curve
NOVO SURGICAL, INC.
5550-36
Not in Commercial Distribution

  • 00842331116131 ()

  • Length: 15 Centimeter
5550-36

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Patent Ductus Clamp - 6 1/4", jaws calibrated at 5.0 mm intervals, 6-1/4" (16.0 cm), angular shanks
NOVO SURGICAL, INC.
5550-08
Not in Commercial Distribution

  • 00842331115875 ()

  • Length: 16 Centimeter
5550-08

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Patent Ductus Clamp - 6 1/4", jaws calibrated at 5.0 mm intervals, 6-1/4" (16.0 cm), straight shanks
NOVO SURGICAL, INC.
5550-06
Not in Commercial Distribution

  • 00842331115868 ()

  • Length: 16 Centimeter
5550-06

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), angled shanks, straight jaws
NOVO SURGICAL, INC.
5550-05
Not in Commercial Distribution

  • 00842331115790 ()

  • Length: 14 Centimeter
5550-05

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), straight shanks, spoon jaws
NOVO SURGICAL, INC.
5550-04
Not in Commercial Distribution

  • 00842331115783 ()

  • Length: 14 Centimeter
5550-04

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), straight shanks, angled jaw
NOVO SURGICAL, INC.
5550-02
Not in Commercial Distribution

  • 00842331115769 ()

  • Length: 14 Centimeter
5550-02

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), straight shanks, straight jaws
NOVO SURGICAL, INC.
5550-01
Not in Commercial Distribution

  • 00842331115752 ()

  • Length: 14 Centimeter
5550-01

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Cooley Anastomosis Clamp, jaws calibrated at 5.0 mm intervals, 6-1/2" (16.5 cm), 6.0 mm jaw depth, standard pattern
NOVO SURGICAL, INC.
C6671-10
In Commercial Distribution

  • 00842331124426 ()

  • Length: 16.5 Centimeter


  • Surgical A/V-shaped microvessel clamp
Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), angled shanks, straight jaws
NOVO SURGICAL, INC.
C6661-16
In Commercial Distribution

  • 00842331123276 ()

  • Length: 14 Centimeter


  • Surgical A/V-shaped microvessel clamp
Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), straight shanks, spoon jaws
NOVO SURGICAL, INC.
C6661-15
In Commercial Distribution

  • 00842331123269 ()

  • Length: 14 Centimeter


  • Surgical A/V-shaped microvessel clamp
Cooley Pediatric Clamp, delicate clamp, jaws calibrated at 5.0 mm intervals, 5-1/2" (14.0 cm), straight shanks, angled jaw
NOVO SURGICAL, INC.
C6661-13
In Commercial Distribution

  • 00842331123245 ()

  • Length: 14 Centimeter


  • Surgical A/V-shaped microvessel clamp
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