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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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REAADS Coagulation Control 2 - 00855360006250

REAADS Coagulation Control 2 (CC-2) ) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use. PRINCIPLE OF THE PROCEDURE Coagulation Control 2 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert.
CORGENIX MEDICAL CORPORATION
702-001
In Commercial Distribution

  • 00855360006250 ()
702-001

  • Multiple coagulation factor IVD, control

exofin Mastic, 2 oz. - 00854137001689

Class 1
Chemence Medical, Inc.
EM80212
Not in Commercial Distribution

  • 00854137001689 ()
EM80212

  • Skin-cover sealant

Plantar Python 2 Right - 00853114006099

Anatomic Tension Side Plate
Treace Medical Concepts, Inc.
SD15
In Commercial Distribution

  • 00853114006099 ()


  • Orthopaedic fixation plate, non-bioabsorbable

Plantar Python 2 Left - 00853114006082

Anatomic Tension Side Plate
Treace Medical Concepts, Inc.
SD14
In Commercial Distribution

  • 00853114006082 ()


  • Orthopaedic fixation plate, non-bioabsorbable

DL4 Replacement Battery 2 - 00855997006487

3.7V 1100mAh lithium-ion battery for S/N DL4A-**** & DL4B-0001 - DL4B-0054
DermLite LLC
DL4B2
In Commercial Distribution

  • 00855997006487 ()
DL4B2

  • Dermatoscope, optical

Ambu AuraStraight Silicone #2 - 05707480105410

Ambu AuraStraight Silicone #2 qty:10
BESMED HEALTH BUSINESS CORP.
342200000
In Commercial Distribution

  • 05707480105410 ()


  • Oropharyngeal airway, single-use

Ambu AuraStraight Silicone #2 - 05707480105403

Ambu AuraStraight Silicone #2
BESMED HEALTH BUSINESS CORP.
342200000
In Commercial Distribution

  • 05707480105403 ()


  • Oropharyngeal airway, single-use

t:flex Cartridge 2 Pack - 00852162004743

t:flex Insulin Pump Cartridges 2 pack
Tandem Diabetes Care, Inc.
007689
In Commercial Distribution

  • 00852162004743 ()
  • 00852162004774 ()

  • Total Volume: 4.8 Milliliter


  • Ambulatory insulin infusion pump reservoir

t:slim Cartridge 2 Pack - 00852162004620

t:slim Cartridge 2 Pack
Tandem Diabetes Care, Inc.
006638
In Commercial Distribution

  • 00852162004620 ()
  • 00852162004767 ()

  • Total Volume: 3 Milliliter


  • Ambulatory insulin infusion pump reservoir

Simplicity 2 Refill Bottle - 00850194007084

Simplicity 2 Refill Bottle
Vista Dental
1
In Commercial Distribution

  • 00850194007084 ()
100-62

  • Dentine bonding agent/set
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