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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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The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
5069-0001-02
In Commercial Distribution

  • 00812101030585 ()
5069-0001-02

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
5069-0001-01
In Commercial Distribution

  • 00812101030578 ()
5069-0001-01

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
5069-0001-00
In Commercial Distribution

  • 00812101030561 ()
5069-0001-00

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial-displacement osteotomies at the calcaneus. This plate is used for the rearfoot.
Ascension Orthopedics, Inc.
2806210
In Commercial Distribution

  • M26928062101 ()
  • 10381780119609 ()

  • 10 mm step
2806210

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial-displacement osteotomies at the calcaneus. This plate is used for the rearfoot.
Ascension Orthopedics, Inc.
2806208
In Commercial Distribution

  • M26928062081 ()
  • 10381780119593 ()

  • 8 mm step
2806208

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial-displacement osteotomies at the calcaneus. This plate is used for the rearfoot.
Ascension Orthopedics, Inc.
2806206
In Commercial Distribution

  • M26928062061 ()
  • 10381780119586 ()

  • 6 mm step
2806206

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Elvarex Soft 2/Capri-BT-Body Bandage/with slip form on both sides with adjustable waist band/Straight Top, slip form without Volant to sew at body bandage/Black
BSN-Jobst GmbH
79457-00007-00
In Commercial Distribution

  • 04019702517880 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 1/Capri-BT-Body Bandage/with slip form on both sides with adjustable waist band/Thigh high slip form without volant to sew at body bandage/Black
BSN-Jobst GmbH
79456-00003-00
In Commercial Distribution

  • 04019702517842 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 3/Capri-B1T-Body Bandage/with slip form on both sides with adjustable waist band/Straight Top, slip form without Volant to sew at body bandage/Black
BSN-Jobst GmbH
79455-00007-00
In Commercial Distribution

  • 04019702517804 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 2/Capri-B1T-Body Bandage/with slip form on both sides with adjustable waist band/Straight Top, slip form without Volant to sew at body bandage/Black
BSN-Jobst GmbH
79454-00007-00
In Commercial Distribution

  • 04019702517767 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
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