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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® - 10381780418375

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® - 10381780418368

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® - 10381780418344

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® - 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® Miltex® - 10381780424864

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® - 10381780424857

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® 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

Integra® Jarit® - 10381780166214

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

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

MR PHACO - G412CA13040

Maumenee Viteous Aspirating Needle 18ga Markings on shaft at 10mm 15mm and 20mm from tip, 25mm Overall Length
Crestpoint Management Limited
CA1304
In Commercial Distribution

  • G412CA13040 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412PH2242T0

Troutman-Barraquer Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, 73mm Overall Length, Titanium
Crestpoint Management Limited
PH2242T
In Commercial Distribution

  • G412PH2242T0 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH10270

Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 90 Degree, .12mm, 73mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH1027
In Commercial Distribution

  • G412PH10270 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH1027

Colibri Corneal Utility Forceps Very Delicate 1x2 Teeth set at 90 Degree, .12mm, 73mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH1027
Not in Commercial Distribution

  • G412PH1027 ()


  • Ophthalmic surgical device handling forceps, reusable

Integra® Miltex® - 10381780495208

Integra® Miltex® Depth Gauge, Ball Tip, Marks at 7, 8, 10, 13, 15, 18 and 20mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
62-170
In Commercial Distribution

  • H834621700 ()
  • 10381780495208 ()
62-170

  • Interproximal dental gauge, reusable

Ambler Surgical - 00190660072285

Rubman-Bores corneal fixation forceps, 4 1/4'', angled shafts, u-shaped, 3.0mm spread, 0.12mm 1x2 teeth at each tip
AMBLER SURGICAL CORP.
Rubman-Bores corneal fixation forceps
In Commercial Distribution

  • 00190660072285 ()
9570E

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

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

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

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

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

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

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

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

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
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