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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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MES 9000 Static Electromyography Scanner - D792N150MES0

Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results. In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise.
MYOTRONICS NOROMED, INC
Static EMG Scanner
In Commercial Distribution

  • D792N150MES0 ()
  • D792N9150 ()


  • Patient monitoring system module, electromyographic

K7 Evaluation System-CMS - D79209940

Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training.
MYOTRONICS NOROMED, INC
K7/CMS
In Commercial Distribution

  • D79209940 ()
  • D79209780 ()


  • Jaw physiology evaluation system

K7 Evaluation System-EMG - D79209930

Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles.
MYOTRONICS NOROMED, INC
K7/EMG
In Commercial Distribution

  • D07920978 ()
  • D79209930 ()


  • Jaw physiology evaluation system

K7 Evaluation System-ESG - D79209750

TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function.
MYOTRONICS NOROMED, INC
K7/ESG
In Commercial Distribution

  • D0792009780 ()
  • D79209750 ()


  • Jaw physiology evaluation system

PureLife Dental - D79011549021

PureLife Level 3 Masks Pink
PURELIFE, LLC
1154902
In Commercial Distribution

  • D79011549023 ()
  • D79011549021 ()
  • D79011549020 ()
1154902

  • Surgical/medical face mask, single-use

PureLife Dental - D79011549011

PureLife Level 3 Masks Blue
PURELIFE, LLC
1154901
In Commercial Distribution

  • D79011549013 ()
  • D79011549011 ()
  • D79011549010 ()
1154901

  • Surgical/medical face mask, single-use

PureLife N95 - D79011548011

PureLife N95 Respirator, Disposable N95, Niosh approved N95 respirator, Headband-style, surgical respirator, Electrostatically-charged filter media provides low breathing resistance, Latex-free, staple-free head straps for comfort and safety, Soft foam nose cushion
PURELIFE, LLC
1154801
In Commercial Distribution

  • D79011548013 ()
  • D79011548011 ()
  • D79011548010 ()
1154801

  • Surgical/medical respirator, non-antimicrobial, single-use

PureLife Dental - D79011501021

Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex-free ear loops, Metal nose piece
PURELIFE, LLC
1150102
In Commercial Distribution

  • D79011501023 ()
  • D79011501021 ()
  • D79011501020 ()
1150102

  • Surgical/medical face mask, single-use

PureLife Dental - D79011430021

Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comfort, Specially-designed tip ensures optimal suction
PURELIFE, LLC
1143002
Not in Commercial Distribution

  • D79011430023 ()
  • D79011430021 ()
  • D79011430020 ()
1143002

  • Dental suction system cannula, single-use

PureLife Dental - D79011103021

4" x 4" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
PURELIFE, LLC
1110302
In Commercial Distribution

  • D79011103020 ()
  • D79011103021 ()
  • D79011103023 ()
1110302

  • Non-woven gauze pad, non-sterile

PureLife Dental - D79011103011

2" x 2" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting
PURELIFE, LLC
1110301
In Commercial Distribution

  • D79011103010 ()
  • D79011103011 ()
  • D79011103013 ()
1110301

  • Non-woven gauze pad, non-sterile

PureHorizon - D79010673041

Large, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recycled material
PURELIFE, LLC
1067304
Not in Commercial Distribution

  • D79010673043 ()
  • D79010673041 ()
  • D79010673040 ()
1067304

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

PureHorizon - D79010673031

Medium, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recycled material
PURELIFE, LLC
1067303
Not in Commercial Distribution

  • D79010673033 ()
  • D79010673031 ()
  • D79010673030 ()
1067303

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Azur - D79010617021

Azur Nitrile Powder-Free, Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061702
In Commercial Distribution

  • D79010617023 ()
  • D79010617021 ()
  • D79010617020 ()
1061702

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Azur - D79010617011

Azur Nitrile Powder-Free, X-Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061701
In Commercial Distribution

  • D79010617013 ()
  • D79010617011 ()
  • D79010617010 ()
1061701

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

SuperNova - D79010612051

SuperNova Nitrile Powder-Free, X-Large, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061205
In Commercial Distribution

  • D79010612053 ()
  • D79010612051 ()
  • D79010612050 ()
1061205

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

SuperNova - D79010612041

SuperNova Nitrile Powder-Free, Large, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061204
In Commercial Distribution

  • D79010612043 ()
  • D79010612041 ()
  • D79010612040 ()
1061204

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

SuperNova - D79010612031

SuperNova Nitrile Powder-Free, Medium, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061203
In Commercial Distribution

  • D79010612033 ()
  • D79010612031 ()
  • D79010612030 ()
1061203

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

SuperNova - D79010612021

SuperNova Nitrile Powder-Free, Small, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061202
In Commercial Distribution

  • D79010612023 ()
  • D79010612021 ()
  • D79010612020 ()
1061202

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

SuperNova - D79010612011

SuperNova Nitrile Powder-Free, X-Small, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061201
In Commercial Distribution

  • D79010612013 ()
  • D79010612011 ()
  • D79010612010 ()
1061201

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601051

Nova Nitrile Powder-Free, X-Large, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060105
In Commercial Distribution

  • D79010601053 ()
  • D79010601051 ()
  • D79010601050 ()
1060105

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601041

Nova Nitrile Powder-Free, Large, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060104
In Commercial Distribution

  • D79010601043 ()
  • D79010601041 ()
  • D79010601040 ()
1060104

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601031

Nova Nitrile Powder-Free, Medium, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060103
In Commercial Distribution

  • D79010601033 ()
  • D79010601031 ()
  • D79010601030 ()
1060103

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601021

Nova Nitrile Powder-Free, Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060102
In Commercial Distribution

  • D79010601023 ()
  • D79010601021 ()
  • D79010601020 ()
1060102

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601011

Nova Nitrile Powder-Free, X-Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060101
In Commercial Distribution

  • D79010601013 ()
  • D79010601011 ()
  • D79010601010 ()
1060101

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

PureGuard - D79010240051

X-Large, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled material, Blue in color
PURELIFE, LLC
1024005
Not in Commercial Distribution

  • D79010240053 ()
  • D79010240051 ()
  • D79010240050 ()
1024005

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

PureGuard - D79010240041

Large, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled material, Blue in color
PURELIFE, LLC
1024004
Not in Commercial Distribution

  • D79010240043 ()
  • D79010240041 ()
  • D79010240040 ()
1024004

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

PureGuard - D79010240031

Medium, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled material, Blue in color
PURELIFE, LLC
1024003
Not in Commercial Distribution

  • D79010240033 ()
  • D79010240031 ()
  • D79010240030 ()
1024003

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

PureGuard - D79010240021

Small, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled material, Blue in color
PURELIFE, LLC
1024002
Not in Commercial Distribution

  • D79010240023 ()
  • D79010240021 ()
  • D79010240020 ()
1024002

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

PureGuard - D79010240011

X-Small, Soft, nitrile powder-free, Textured fingertips, Packaging contains recycled material, Blue in color
PURELIFE, LLC
1024001
Not in Commercial Distribution

  • D79010240013 ()
  • D79010240011 ()
  • D79010240010 ()
1024001

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Unipack - D784UTT10011

Clip Cord Covers 2" x 1200' BlackCat
UNIPACK MEDICAL CORPORATION
UTT-1001
In Commercial Distribution

  • D784UTT10015 ()
  • D784UTT10011 ()
UTT-1001

  • Medical equipment/instrument drape, single-use

Unipack - D784UST90751

Aspirator Tips Blue 1/16" x 7-1/4"
UNIPACK MEDICAL CORPORATION
UST-9075
In Commercial Distribution

  • D784UST90755 ()
  • D784UST90751 ()
  • D784UST90750 ()
UST-9075

  • Dental suction system cannula, single-use

Unipack - D784UST90741

Aspirator Tips Green 1/4" x 6-1/4"
UNIPACK MEDICAL CORPORATION
UST-9074
In Commercial Distribution

  • D784UST90745 ()
  • D784UST90741 ()
  • D784UST90740 ()
UST-9074

  • Dental suction system cannula, single-use

Unipack - D784UST90731

Aspirator Tips White 1/8" x 6-1/4"
UNIPACK MEDICAL CORPORATION
UST-9073
In Commercial Distribution

  • D784UST90735 ()
  • D784UST90731 ()
  • D784UST90730 ()
UST-9073

  • Dental suction system cannula, single-use

Unipack - D784URS559001

Impression Syringes 5ml
UNIPACK MEDICAL CORPORATION
URS-55900
In Commercial Distribution

  • D784URS559005 ()
  • D784URS559001 ()
  • D784URS559000 ()
URS-55900

  • Dental impression material syringe, single-use

Unipack - D784URS551121

Utility Syringes Curved 12cc
UNIPACK MEDICAL CORPORATION
URS-55112
In Commercial Distribution

  • D784URS551125 ()
  • D784URS551121 ()
  • D784URS551120 ()
URS-55112

  • Dental impression material syringe, single-use

Unipack - D784URN553301

Irrigation Probes 30G Side Port Luer Lock, Purple
UNIPACK MEDICAL CORPORATION
URN-55330
In Commercial Distribution

  • D784URN553305 ()
  • D784URN553301 ()
  • D784URN553300 ()
URN-55330

  • Root canal irrigation blunt needle

Unipack - D784URN553271

Irrigation Probes 27G Side Port Luer Lock, Yellow
UNIPACK MEDICAL CORPORATION
URN-55327
In Commercial Distribution

  • D784URN553275 ()
  • D784URN553271 ()
  • D784URN553270 ()
URN-55327

  • Root canal irrigation blunt needle

Unipack - D784URN553231

Irrigation Probes 23G Side Port Luer Lock, Blue
UNIPACK MEDICAL CORPORATION
URN-55323
In Commercial Distribution

  • D784URN553235 ()
  • D784URN553231 ()
  • D784URN553230 ()
URN-55323

  • Root canal irrigation blunt needle

Unipack - D784URN552301

Irrigation Needle Tips 30G Notched Purple /Luer Lock
UNIPACK MEDICAL CORPORATION
URN-55230
In Commercial Distribution

  • D784URN552305 ()
  • D784URN552301 ()
  • D784URN552300 ()
URN-55230

  • Root canal irrigation blunt needle
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