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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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Elvarex Soft 2/Bermuda panty/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
79572-00007-00
In Commercial Distribution

  • 04019702512335 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Soft 1/Capri-CT-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
79580-00003-00
In Commercial Distribution

  • 04019702510638 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable
Atrium Health At Home O2 Kit This kit contains: (2) RES001, (1) RES012, (2) RES018, (6) RES1107S, (2) RES3040G, (1) RES003, (1) RES050, (1) HUM008S-1, (1) RES019
SUNSET HEALTHCARE SOLUTIONS, INC.
ATRIUMHAHO2KIT
In Commercial Distribution

  • 00848530105792 ()


  • Oxygen administration kit
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
The DRI™ 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
10028872
In Commercial Distribution

  • 00812101030752 ()
10028872

  • 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 MediOX is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment.
Braebon Medical Corporation
MD-O
In Commercial Distribution

  • B140MDO0 ()
MD-O

  • Polysomnograph
Acid Phosphatase Reagent Set for the quantitative determination of acid phosphatase in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 6 x 10ml
POINTE SCIENTIFIC, INC.
HA703-60
In Commercial Distribution

  • 00811727012210 ()
HA703-60

  • Total/prostatic acid phosphatase (TcP) IVD, kit, spectrophotometry
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