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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ST MARKS HAND RETRACTOR WITH LIP AND FIBER OPTIC LIGHT CARRIER/UNIVERSAL CONNECTOR ANGLED 15 DEGREES AT TIP
SONTEC INSTRUMENTS, INC.
508-327L
In Commercial Distribution

  • 00192896044456 ()

  • Blade Length 11 Inch
508-327L

  • Hand-held surgical retractor, reusable
ST MARKS HAND RETRACTOR WITH LIP AND FIBER OPTIC LIGHT CARRIER/UNIVERSAL CONNECTOR ANGLED 15 DEGREES AT TIP
SONTEC INSTRUMENTS, INC.
508-326L
In Commercial Distribution

  • 00192896044425 ()

  • Blade Length 9 Inch
508-326L

  • Hand-held surgical retractor, reusable
V. Mueller Neuro/Spine MULTI-HOLE SUCTION TUBE 5 HOLES AT TIP WORKING LENGTH 6-1/4 inches 160MM 5FR
STERIS CORPORATION
G-0045
In Commercial Distribution

  • 10885403041709 ()
G0045

  • Surgical/emergency suction cannula, non-illuminating, reusable
V. Mueller Neuro/Spine MULTI-HOLE SUCTION TUBE 5 HOLES AT TIP WORKING LENGTH 4-1/2 inches 115MM 7FR
STERIS CORPORATION
G-0040
In Commercial Distribution

  • 10885403041679 ()
G0040

  • Surgical/emergency suction cannula, non-illuminating, reusable
V. Mueller Neuro/Spine MULTI-HOLE SUCTION TUBE 5 HOLES AT TIP WORKING LENGTH 4-1/2 inches 115MM 5FR
STERIS CORPORATION
G-0039
In Commercial Distribution

  • 10885403041662 ()
G0039

  • Surgical/emergency suction cannula, non-illuminating, reusable
V. Mueller Neuro/Spine MULTI-HOLE SUCTION TUBE 5 HOLES AT TIP WORKING LENGTH 6-1/4 inches 160MM 7FR
STERIS CORPORATION
G-0046
In Commercial Distribution

  • 10885403041716 ()
G0046

  • Surgical/emergency suction cannula, non-illuminating, reusable
V. Mueller FANSLER PROCTOSCOPE OPEN AT TOP DIAMETER 1-1/3 inches 3.3CM WORKING LENGTH 2-3/8 inches 6CM
STERIS CORPORATION
SU220
In Commercial Distribution

  • 10885403060946 ()
SU220

  • Optical proctoscope, reusable
Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display
Fotonmedix Medical Laser Co., LTD
LaserMedix4500U1
In Commercial Distribution

  • 06976487170007 ()


  • Musculoskeletal/physical therapy laser, professional
For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7723
In Commercial Distribution

  • 07331791015854 ()
  • 07331791017100 ()
7723

  • Tracheostoma protective filter
For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7707
In Commercial Distribution

  • 07331791016738 ()
  • 07331791009693 ()
7707

  • Tracheostoma protective filter
For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.
Atos Medical AB
7704
In Commercial Distribution

  • 07331791016721 ()
  • 07331791002861 ()
7704

  • Tracheostoma protective filter
VOMIT AND URINE CLEAR BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" RIGID OPENING AT THE TOP
KENTRON HEALTHCARE, INC.
404086
In Commercial Distribution

  • 00810003751225 ()
  • 00810003751218 ()
  • 00810003751232 ()
404086

  • Emesis bag
R195 - The PDT 12 Probe is a single-end probe with markings at 3-6-9-12mm coupled with a mobility probe.
PDT, INC.
R195 Probe 12 (3-6-9-12)
In Commercial Distribution

  • 00813677021199 ()
R195

  • Dental surgical probe, reusable
R194 - The PDT 11 Probe is a single-end probe with markings at 3-6-8-11mm coupled with a mobility probe.
PDT, INC.
R194 Probe 11 (3-6-8-11)
In Commercial Distribution

  • 00813677021182 ()
R194

  • Dental surgical probe, reusable
cooley anastomosis clamp, jaws calibrated at 5.0 mm intervals, 6 1/2" (16.5 cm), 7.0 mm jaw depth
NOVO SURGICAL, INC.
5560-11
Not in Commercial Distribution

  • 00842331118586 ()

  • Length: 16.5 Centimeter


  • Vascular Doppler clamp
Provent 30 Night Starter Kit contains two (2) Light resistance (Phase 1) non-therapeutic acclimation units, two (2) Medium resistance (Phase 2) non-therapeutic acclimation units, and 26 Standard resistance Provent devices
PROVENT SLEEP THERAPY, LLC
CAT1114
In Commercial Distribution

  • 00868020000215 ()

  • Expiratory Resistance 0.5 >= x <1.5 cm H2O at 50 mL/sec flow rate per nostril
  • Expiratory Resistance 1.5 >= x <3.0 cm H2O at 50 mL/sec flow rate per nostril
  • Expiratory Resistance 3.0 >= x <8.0 cm H2O at 50 mL/sec flow rate per nostril
CAT1114

  • Nasal dilator
The First Device featuring PRISM Technology. Global patent including US Patent No. US 7.841.224 B2 & US 8.250.900 B2, Accuracy: +/- 0.01 at 0.10 g/dL (%BAC), Sensor module must be replaced every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM6000
In Commercial Distribution

  • 00853464001089 ()
AKG SM6000

  • Alcohol breath analyser
Koch Mendez Fixation Ring, beveled degree gauge with teeth, handle mounted at 135 degrees, works well with our E3-4011, 5 degree ruler markings on top of unique bevel (labeled at 30 degree increments), round knurled handle, Titanium (with stainless color)
Hayden Medical, Inc.
E3-4069T
In Commercial Distribution

  • 00840319726525 ()
E3-4069T

  • Corneal marker, reusable
Koch Mendez Fixation Ring, Beveled Degree Gauge with teeth, Handle Mounted at 135 Degrees, Works well with our CM-0402, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Round Knurled Handle, Titanium (with Stainless color)
Crestpoint Management Limited
PH9409T
In Commercial Distribution

  • G412PH9409T0 ()


  • Medical ruler, reusable
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.
X5
In Commercial Distribution

  • 06972480916383 ()


  • 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.
X8
In Commercial Distribution

  • 06972480913269 ()


  • 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.
X11
In Commercial Distribution

  • 06972480913054 ()


  • 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.
X8
In Commercial Distribution

  • 06972480913047 ()


  • 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.
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
Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, minus 6" length, patented Size M
Lac-Mac Limited
005XFAQ-M
In Commercial Distribution

  • 00627755531124 ()

  • Height: 57.25 Inch
005XFAQ-M

  • Surgical gown, reusable
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 Revi
In Commercial Distribution

  • 00852116008186 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30 ProZ
In Commercial Distribution

  • 00852116008179 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/405nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Revi
Not in Commercial Distribution

  • 00852116008087 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 0.8 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Home
Not in Commercial Distribution

  • 00852116008070 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProX
Not in Commercial Distribution

  • 00852116008063 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProZ
Not in Commercial Distribution

  • 00852116008056 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 0.8 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-P
Not in Commercial Distribution

  • 00852116008025 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Z
Not in Commercial Distribution

  • 00852116008001 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-X
Not in Commercial Distribution

  • 00852116008018 ()


  • Musculoskeletal/physical therapy laser, professional
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
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 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
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
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
Beck Vascular Clamp, cooley jaws calibrated at 5.0 mm intervals, straight shanks, 6" (15.0 cm), large jaw, medium curve
NOVO SURGICAL, INC.
C6661-48
In Commercial Distribution

  • 00842331123627 ()

  • Length: 15 Centimeter


  • Surgical A/V-shaped microvessel clamp
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