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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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Revive - 00854389008009

The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
RINOVUM SUBSIDIARY 2, LLC
0025
In Commercial Distribution

  • 20854389008027 ()
  • 10854389008020 ()
  • 00854389008023 ()
  • 00854389008009 ()
0025

  • Urinary-incontinence vaginal insert, reusable

Phospholin ES w/Calcium - 10859394006238

APTT reagent 5 x 5 ml
R 2 DIAGNOSTICS, INC.
21-405
In Commercial Distribution

  • 10859394006238 ()
  • 00859394006231 ()
21-405

  • Activated partial thromboplastin time (APTT) IVD, reagent

FIB Calibrator - 10859394006191

Fibrinogen Reference Plasma 10 x 1 ml
R 2 DIAGNOSTICS, INC.
71-201
In Commercial Distribution

  • 10859394006191 ()
  • 00859394006194 ()
71-201

  • Plasma protein IVD, calibrator

PlasmaRef ARL-2 - 10859394006184

Assayed Reference Plasma L-2 10 x 1 ml
R 2 DIAGNOSTICS, INC.
35-201
In Commercial Distribution

  • 10859394006184 ()
  • 00859394006187 ()
35-201

  • Plasma protein IVD, calibrator

PlasmaRef ARN - 10859394006177

Assayed Reference Plasma 10 x 1 ml
R 2 DIAGNOSTICS, INC.
33-201
In Commercial Distribution

  • 10859394006177 ()
  • 00859394006170 ()
33-201

  • Plasma protein IVD, calibrator

NoFact IX - 10859394006160

Factor IX immunodepleted 10 x 1 ml
R 2 DIAGNOSTICS, INC.
69-201
In Commercial Distribution

  • 10859394006160 ()
  • 00859394006163 ()
69-201

  • Coagulation factor IX IVD, kit, clotting

NoFact VIII - 10859394006153

Factor VIII immunodepleted 10 x 1 ml
R 2 DIAGNOSTICS, INC.
68-201
In Commercial Distribution

  • 10859394006153 ()
  • 00859394006156 ()
68-201

  • Coagulation factor VIII IVD, kit, clotting

LupoTek KCT - 10859394006146

Screening test for LA 250 DET
R 2 DIAGNOSTICS, INC.
87-305
In Commercial Distribution

  • 10859394006146 ()
  • 00859394006149 ()
87-305

  • Lupus anticoagulant marker IVD, kit, clotting

PlasmaCon LA - 10859394006139

Positive control for LA 10 x 1 ml
R 2 DIAGNOSTICS, INC.
150-201
In Commercial Distribution

  • 10859394006139 ()
  • 00859394006132 ()
150-201

  • Multiple coagulation factor IVD, control

PlasmaCon LA - 10859394006122

Positive control for LA 10 x 0.5 ml
R 2 DIAGNOSTICS, INC.
150-200
In Commercial Distribution

  • 10859394006122 ()
  • 00859394006125 ()
150-200

  • Multiple coagulation factor IVD, control
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