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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IMPIX-MANTA 19.5x14x7mm at 3°
MEDICREA INTERNATIONAL
B20121973
Not in Commercial Distribution

  • 03613720230816 ()
B20121973

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 19.5x14x6mm at 3°
MEDICREA INTERNATIONAL
B20121963
Not in Commercial Distribution

  • 03613720230809 ()
B20121963

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 19.5x14x5mm at 3°
MEDICREA INTERNATIONAL
B20121953
Not in Commercial Distribution

  • 03613720230793 ()
B20121953

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x9mm at 6°
MEDICREA INTERNATIONAL
B20121796
Not in Commercial Distribution

  • 03613720230786 ()
B20121796

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x9mm at 3°
MEDICREA INTERNATIONAL
B20121793
Not in Commercial Distribution

  • 03613720230779 ()
B20121793

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x9mm at 0°
MEDICREA INTERNATIONAL
B20121790
Not in Commercial Distribution

  • 03613720230762 ()
B20121790

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x8mm at 6°
MEDICREA INTERNATIONAL
B20121786
Not in Commercial Distribution

  • 03613720230755 ()
B20121786

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x8mm at 3°
MEDICREA INTERNATIONAL
B20121783
Not in Commercial Distribution

  • 03613720230748 ()
B20121783

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x8mm at 0°
MEDICREA INTERNATIONAL
B20121780
Not in Commercial Distribution

  • 03613720230731 ()
B20121780

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x7mm at 6°
MEDICREA INTERNATIONAL
B20121776
Not in Commercial Distribution

  • 03613720230724 ()
B20121776

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x7mm at 3°
MEDICREA INTERNATIONAL
B20121773
Not in Commercial Distribution

  • 03613720230717 ()
B20121773

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x7mm at 0°
MEDICREA INTERNATIONAL
B20121770
Not in Commercial Distribution

  • 03613720230700 ()
B20121770

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x6mm at 6°
MEDICREA INTERNATIONAL
B20121766
Not in Commercial Distribution

  • 03613720230694 ()
B20121766

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x6mm at 3°
MEDICREA INTERNATIONAL
B20121763
Not in Commercial Distribution

  • 03613720230687 ()
B20121763

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x6mm at 0°
MEDICREA INTERNATIONAL
B20121760
Not in Commercial Distribution

  • 03613720230670 ()
B20121760

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x5mm at 6°
MEDICREA INTERNATIONAL
B20121756
Not in Commercial Distribution

  • 03613720230663 ()
B20121756

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x5mm at 3°
MEDICREA INTERNATIONAL
B20121753
Not in Commercial Distribution

  • 03613720230656 ()
B20121753

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x5mm at 0°
MEDICREA INTERNATIONAL
B20121750
Not in Commercial Distribution

  • 03613720230649 ()
B20121750

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x10mm at 6°
MEDICREA INTERNATIONAL
B20121706
Not in Commercial Distribution

  • 03613720230632 ()
B20121706

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x10mm at 3°
MEDICREA INTERNATIONAL
B20121703
Not in Commercial Distribution

  • 03613720230625 ()
B20121703

  • Polymeric spinal interbody fusion cage
IMPIX-MANTA 17x14x10mm at 0°
MEDICREA INTERNATIONAL
B20121700
Not in Commercial Distribution

  • 03613720230618 ()
B20121700

  • Polymeric spinal interbody fusion cage
AT tissue forceps DEBAKEY
A. Schweickhardt GmbH & Co. KG
17248-20
In Commercial Distribution

  • E89617248200 ()
17248-20

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
AT tissue forceps DEBAKEY
A. Schweickhardt GmbH & Co. KG
17246-20
In Commercial Distribution

  • E89617246200 ()
17246-20

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
AT tissue forceps DEBAKEY
A. Schweickhardt GmbH & Co. KG
17228-15
In Commercial Distribution

  • E89617228150 ()
17228-15

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
AT HOME MULTI-DRUG TEST
FOURSTAR GROUP INC.
11012637M
In Commercial Distribution

  • 00049696708319 ()


  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
O2/AT/OT/CB
BSN-Jobst GmbH
73550-00160-00
In Commercial Distribution

  • 04019702984682 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
O2/AT/CT/CB
BSN-Jobst GmbH
73550-00148-00
In Commercial Distribution

  • 04019702244595 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
O2/AT/OT/NA
BSN-Jobst GmbH
73550-00002-00
In Commercial Distribution

  • 04019702243444 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
O3/AT/OT/BL
BSN-Jobst GmbH
73556-00004-00
In Commercial Distribution

  • 04019702240689 ()

  • PRESSURE 34-46 MMHG


  • Compression/pressure sock/stocking, reusable
AT vasc clamp 29.0cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
55.58.27
In Commercial Distribution

  • 04046826074821 ()
55.58.27

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
AT vasc clamp 19.5cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
55.58.19
In Commercial Distribution

  • 04046826074814 ()
55.58.19

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
AT vasc clamp 18.5cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
55.58.18
In Commercial Distribution

  • 04046826074807 ()
55.58.18

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Dry blood spot card collection kit utilizing 903 Five Spot Blood Card and Hologic Aptima Urine transport tube.
Blackfly Investments, LLC
STI collection kit
In Commercial Distribution

  • 00860008357847 ()
50428654200

  • Dried blood spot collection kit IVD
  • Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
  • Blood collection paper
Dry blood spot collection kit using 903 Five Spot Blood card
Blackfly Investments, LLC
Thyroid collection kit
In Commercial Distribution

  • 00860008357830 ()
50428654637

  • Blood collection paper
  • Dried blood spot collection kit IVD
Dry blood spot card collection kit utilizing 903 Five Spot Blood card.
Blackfly Investments, LLC
Lyme Disease Collection Kit
In Commercial Distribution

  • 00860008357823 ()
50428653890

  • Blood collection paper
  • Dried blood spot collection kit IVD
Dry blood spot collection kit using 903 Five Spot Blood card
Blackfly Investments, LLC
Vitamin D collection kit
In Commercial Distribution

  • 00860008357816 ()
50428656679

  • Dried blood spot collection kit IVD
  • Blood collection paper
Dry blood spot card collection kit utilizing 903 Five Spot Blood Card card.
Blackfly Investments, LLC
Food Sensitivity collection
Not in Commercial Distribution

  • 00860008357809 ()
50428654057

  • Blood collection paper
  • Dried blood spot collection kit IVD
Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
RESPIRE MEDICAL HOLDINGS LLC
SPAT000US
In Commercial Distribution

  • 00851861007260 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Intraoral appliance indicated to treat mild to moderate Obstructive Sleep Apnea (OSA) in patients, 18 years of age or older.
RESPIRE MEDICAL HOLDINGS LLC
SPAT030US
In Commercial Distribution

  • 00851861007253 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
HemosIL Liquid AT Substrate 6X2 ML
INSTRUMENTATION LABORATORY COMPANY
00020002600
Not in Commercial Distribution

  • 08426950087571 ()
  • 18426950087578 ()
00020002600

  • Antithrombin III (ATIII) IVD, reagent
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