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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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Instrument used to place the cap of the WasherCap™ Fixation System at the entrance of the tunnel.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739485 ()
  • 28437019739489 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Integra® Miltex® Cleveland Oral Surgery Rongeur 5-1/4", No. 5S, Side Cutting, Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-428
In Commercial Distribution

  • H83422D4280 ()
  • 10381780424864 ()
22D-428

  • Dental rongeur
Integra® Miltex® Cleveland Oral Surgery Rongeur 6-1/2", No. 5A, Side Cutting, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22D-426
In Commercial Distribution

  • H83422D4260 ()
  • 10381780424857 ()
22D-426

  • Dental rongeur
Integra® Miltex® Cleveland Oral Surgery Rongeur 6-1/2", No. 5, Side Cutting, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
22-490
In Commercial Distribution

  • H834224900 ()
  • 10381780424703 ()
22-490

  • Dental rongeur
Integra® Miltex® Lester Fixation Forceps 3-7/8", Delicate, 2 x 3 Teeth, 1.1mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-914
In Commercial Distribution

  • H834189140 ()
  • 10381780418375 ()

  • Width: 1.1 Millimeter
  • 3-7/8"
18-914

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Lester Fixation Forceps, 3-7/8", Delicate, 1 x 2 Teeth, 0.55mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-912
In Commercial Distribution

  • H834189120 ()
  • 10381780418368 ()

  • Width: 0.55 Millimeter
  • 3-7/8"
18-912

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® O'Brien Fixation Forceps, 4", 1 x 2 Teeth, Angled Forward, 0.75mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-904
In Commercial Distribution

  • H834189040 ()
  • 10381780418344 ()

  • Length: 4 Inch
  • Width: 0.75 Millimeter
18-904

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Bishop-Harmon Tissue Forceps 3-3/8", Standard, 1 x 2 Teeth, 0.6mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-868
In Commercial Distribution

  • H834188680 ()
  • 10381780418252 ()

  • 3-3/8"
  • Width: 0.6 Millimeter
  • 1 x 2 Teeth
18-868

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Miltex® Iris Tissue Forceps 4", Standard, Straight, 1 x 2 Teeth, 0.8mm wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
18-786
In Commercial Distribution

  • H834187860 ()
  • 10381780417897 ()
18-786

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Jarit® Lester Fixation Forceps, 3-7/8", Delicate, 1 x 2 Teeth, 0.55mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
355140
In Commercial Distribution

  • M2743551401 ()
  • 10381780166214 ()

  • 3-7/8"
  • Width: 0.55 Millimeter
355-140

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Integra® Jarit® Cleveland Oral Surgery Rongeur 5-1/4", No. 5S, Side Cutting, Jaws at 30° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33E539
In Commercial Distribution

  • M274X33E5391 ()
  • 10381780407867 ()
X33E539

  • Dental rongeur
Integra® Jarit® Cleveland Oral Surgery Rongeur 6-1/2", No. 5A, Side Cutting, Jaws at 25° Angle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X33E537
In Commercial Distribution

  • M274X33E5371 ()
  • 10381780407850 ()
X33E537

  • Dental rongeur
Nagahara Hydrodissection Cannula, 27 Gauge, Gentle angled tip at 35° with vertical flat spatulated tip, 24mm tip length
Diamatrix
C554-35
In Commercial Distribution

  • 00813059015440 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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
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
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
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
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.
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
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
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 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
Elvarex 3/Thigh High/Closed Toe, Knee Comfort/Thigh high slip form without volant to sew at body bandage
BSN-Jobst GmbH
77567-00782-00
In Commercial Distribution

  • 04019702290578 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
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