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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 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
Stainless Steel Square Grip Handle Bayonet Bipolar Forcep 7 3/4" (196.85mm) Irrigating And Insulated With A With A Straight 0.25mm Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
263918439010101
In Commercial Distribution

  • 00817914024066 ()

  • Length: 196.85 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Blue Titanium M-Style Square Grip Handle Bayonet Bipolar Forcep 8 3/4" (222.25mm) With A Gold 10mm Area With A 0.25mm Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
183910147010101
In Commercial Distribution

  • 00817914023076 ()

  • Length: 8.75 Inch


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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
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 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)
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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