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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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BPro® Ambulatory Blood Pressure Monitoring System - 08885014410012

BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410012 ()


  • Blood pressure ambulatory recorder

Provent Sleep Therapy - 00868020000208

Provent 30 Night Standard Pack contains 30 Standard resistance Provent
PROVENT SLEEP THERAPY, LLC
CAT1105
In Commercial Distribution

  • 00868020000208 ()

  • Expiratory Resistance 3.0 >= x < 8.0 cm H2O at 50 mL/sec flow rate per nostril
CAT1105

  • Nasal dilator

Power Dental USA - D94381007

PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II,DUS5 SHARP AT THREE SIDES HARVESTER TO HARVEST AUTOGENOUS BONE BLOCKS, RIDGE.
Power Dental U.S.A. Inc.
8100-7
In Commercial Distribution

  • D94381007 ()
8100-7

  • Dressing/utility forceps, scissors-like, reusable
  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

CORTAC® - 00650551050100

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093
In Commercial Distribution

  • 00650551050100 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-093

  • Cortical electrode

CORTAC® - 00650551087410

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066-NS
In Commercial Distribution

  • 00650551087410 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066-NS

  • Cortical electrode

CORTAC® - 00650551087403

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066-NS
In Commercial Distribution

  • 00650551087403 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-066-NS

  • Cortical electrode

CORTAC® - 00650551087335

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062-NS
In Commercial Distribution

  • 00650551087335 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111TX-16-062-NS

  • Cortical electrode

CORTAC® - 00650551087328

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062-NS
In Commercial Distribution

  • 00650551087328 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-062-NS

  • Cortical electrode

CORTAC® - 00650551074670

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093-NS
In Commercial Distribution

  • 00650551074670 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-093-NS

  • Cortical electrode

CORTAC® - 00650551062844

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066
In Commercial Distribution

  • 00650551062844 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066

  • Cortical electrode

CORTAC® - 00650551062837

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066
In Commercial Distribution

  • 00650551062837 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-066

  • Cortical electrode

CORTAC® - 00650551062769

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062
In Commercial Distribution

  • 00650551062769 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-062

  • Cortical electrode

CORTAC® - 00650551062752

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062
In Commercial Distribution

  • 00650551062752 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-062

  • Cortical electrode

AlcoMate - 00853464001119

The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM7000
In Commercial Distribution

  • 00853464001119 ()
AKG SM7000

  • Alcohol breath analyser

Transport shelf - 00670482000722

The transport shelf is an accessory. It's intended to be installed at foot end of the bed in the corner bumper.
Umano Medical Inc
299-0523WG-TRI
In Commercial Distribution

  • 00670482000722 ()
  • 10670482000729 ()


  • Basic electric hospital bed

ever GUIDE KIT - 08806343924049

It is used when removing the gums at the location where the fixture will be installed during dental implant fixture surgery.
Shinhung MST Co., Ltd.
GTP35
In Commercial Distribution

  • 08806343924049 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port - 00840117305885

Adult/Ped: Tidal Volume Range(300-1500mL), Breathing Resistance(1.8cm H2O at 60L/min, Media(Corrugated Paper), Dead Space(15mL), Weight(8.4g)
Dynarex Corporation
30309
In Commercial Distribution

  • 00840117305892 ()
  • 00840117305885 ()


  • Heat/moisture exchanger, single-use

Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port - 00840117305472

Pediatric, Tidal Volume Range(70-600mL), Media(Foam), Dead Space(21mL), Breathing Resistance(2.2cm H2O at 60 L/min), Weight(9g), Pediatric
Dynarex Corporation
30205
In Commercial Distribution

  • 00840117305489 ()
  • 00840117305472 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Hygroscopic Condenser Humidifier (HMEF) 600 B/V Filter, CO2 Port - 00840117305373

Pediatric, Tidal Volume Range(70-600mL), Media(Foam + Flat Media), Dead Space(19mL), Breathing Resistance(1.6cm H2O at 30L /min), Weight(19g)
Dynarex Corporation
30107
In Commercial Distribution

  • 00840117305380 ()
  • 00840117305373 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000 CO2 Port, Low Profile - 00840117305311

Adult, Tidal Volume Range( 150-1000mL), Media (Foam+ Flat Media), Dead Space (43mL), Breathing Resistance (1.9cm H2O at 60L /min), Weight (21g)
Dynarex Corporation
30104
In Commercial Distribution

  • 00840117305328 ()
  • 00840117305311 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube - 00840117318090

Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(90mL), Breathing Resistance (1.6cm H2O at 60 L/min), Weight(15.5g). Adult/Pediatric
Dynarex Corporation
30202
In Commercial Distribution

  • 00840117318083 ()
  • 00840117318090 ()


  • Heat/moisture exchanger, single-use

Rumex - 00840159904053

Utrata Capsulorhexis Forceps With Scale (2 Engravings At 3.00, 6.00 mm), Cystotome Tips, Curved Jaws, Round Handle, Length 110 mm, Titanium
RUMEX INTERNATIONAL CORP.
4-03314T
In Commercial Distribution

  • 00840159904053 ()
4-03314T

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

Rumex - 00840159904039

Utrata Capsulorhexis Forceps With Scale (2 Engravings at 3.00, 6.00 mm), Cystotome Tips, Straight jaws, Round Handle, Length 110 mm, Titanium
RUMEX INTERNATIONAL CORP.
4-03114T
In Commercial Distribution

  • 00840159904039 ()
4-03114T

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

Ambler Surgical - 00190660058647

Katzin-Barraquer colibri corneal utility forceps, 2 7/8'', 0.5mm 1x2 teeth set at 45 degrees with 7.5mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Katzin-Barraquer colibri corneal utility forceps
In Commercial Distribution

  • 00190660058647 ()
2239E

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

Ambler Surgical - 00190660057008

Hyde colibri corneal forceps, 4 1/4'', 0.12mm 2x2 teeth set at 45 degrees, with 7.0mm tying platform, flat 3-hole handle
AMBLER SURGICAL CORP.
Hyde colibri corneal forceps
In Commercial Distribution

  • 00190660057008 ()
9522E

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

Ambler Surgical - 00190660055615

Harms colibri forceps, 3'', very delicate 0.12mm, 1x2 teeth set at 45 degrees, 6.0mm TC dusted tying platform, flat handle, titanium
AMBLER SURGICAL CORP.
Harms colibri forceps
In Commercial Distribution

  • 00190660055615 ()
2364T

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

Ambler Surgical - 00190660055592

Harms colibri forceps, 2 3/4'', very delicate 0.2mm, 1x2 teeth set at 45 degrees, 5.0mm tying platform, flat handle, titanium
AMBLER SURGICAL CORP.
Harms colibri forceps
In Commercial Distribution

  • 00190660055592 ()
9510T

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

Ambler Surgical - 00190660054168

Girard corneoscleral forceps, 4 1/4'', right hand use, 0.12mm 1x2 teeth set at 90 degrees, 6.0mm tying platforms, round handle
AMBLER SURGICAL CORP.
Girard corneoscleral forceps
In Commercial Distribution

  • 00190660054168 ()
2345E

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

Ambler Surgical - 00190660054151

Girard corneoscleral forceps, 4 1/4'', left hand use, 0.3mm 1x2 teeth set at 90 degrees, 6.0mm tying platforms, round handle
AMBLER SURGICAL CORP.
Girard corneoscleral forceps
In Commercial Distribution

  • 00190660054151 ()
2342E

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

Ambler Surgical - 00190660054144

Girard corneoscleral forceps, 4 1/4'', left hand use, 0.12mm 1x2 teeth set at 90 degrees, 6.0mm tying platforms, round handle
AMBLER SURGICAL CORP.
Girard corneoscleral forceps
In Commercial Distribution

  • 00190660054144 ()
2344E

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