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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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Integra® Miltex® - 10381780418252

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® - 10381780417897

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® - 10381780195917

Integra® Jarit® Lester Fixation Forceps, 3-7/8", Delicate, 2 x 3 Teeth, 1.1mm Wide at Tip
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
355141
In Commercial Distribution

  • M2743551411 ()
  • 10381780195917 ()

  • Width: 1.1 Millimeter
  • 3-7/8"
355-141

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Diamatrix - 00813059015440

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

KENOREX - 00810003751218

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

FOTONMEDIX - 06976487170007

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

ISolate Ready to Use Density Gradient Medium - 00810195240361

ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 1x100mL Upper Layer and 1x100mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-2x100ML
In Commercial Distribution

  • 00810195240361 ()
99264

  • IVF medium

ISolate Ready to Use Density Gradient Medium - 00810195240354

ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 6x6mL Upper Layer and 6x6mL Lower Layer.
IRVINE SCIENTIFIC, LLC
99264-12x6ML
In Commercial Distribution

  • 00810195240354 ()
99264

  • IVF medium

Integra® Jarit® - 10381780407867

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® - 10381780407850

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

TrachPhone (5 pcs) - 07331791015854

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

TrachPhone (30 pcs) - 07331791009693

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

TrachPhone (50 pcs) - 07331791002861

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

PDT, Inc. - 00813677021199

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

PDT, Inc. - 00813677021182

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

Novo Surgical - 00842331118586

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

AlcoMate - 00853464001089

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

Hayden Medical - 00840319726525

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

MR PHACO - G412PH9409T0

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

AILE Electronic Sphygmomanometers - 06972480916383

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

COOCEER Electronic Sphygmomanometers - 06972480913269

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

AILE Electronic Sphygmomanometers - 06972480913054

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

AILE Electronic Sphygmomanometers - 06972480913047

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

AILE Electronic Sphygmomanometers - 06972480913030

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

AILE Electronic Sphygmomanometers - 06972480913023

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

AILE Electronic Sphygmomanometers - 06972480913009

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

AILE Electronic Sphygmomanometers - 06972480912996

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

Provent Sleep Therapy - 00868020000215

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

xReader System - 00867802000290

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

LZ30 - 00852116008186

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

LZ30 - 00852116008179

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

LZ30 - 00852116008087

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

LZ30 - 00852116008070

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

LZ30 - 00852116008063

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

LZ30 - 00852116008056

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

LZ30 - 00852116008025

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

LZ30 - 00852116008018

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

LZ30 - 00852116008001

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

FlexBoard Wrist Support - 10815614020262

The FlexBoard Model 4400 is an adjustable wrist support device that extends the patient's wrist at a desired angle.
Semler Technologies, Inc.
4400
In Commercial Distribution

  • 20815614020269 ()
  • 10815614020262 ()
140-0400-00

  • Wrist immobilizer, single-use

Wrist Assist Wrist Support - 10815614020170

The WristAssist Model 4300 is a wrist support device that extends the patient's wrist at a consistent 30° angle.
Semler Technologies, Inc.
4300
In Commercial Distribution

  • 20815614020177 ()
  • 10815614020170 ()
  • 30815614020174 ()
140-0300-00

  • Wrist immobilizer, single-use
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