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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 Intellipac Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-2560-01
In Commercial Distribution

  • 10850009370201 ()
  • 30850009370205 ()
03-2560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
Intelio Programmer System consists of: (1) Intelio Programming Interface (1) Getac RX10 Tablet (1) Getac RX10 Charger (1) Intelio Programming Interface - Back Lid (1) Intelio Programming Wand (1) Legacy Programming Wand (1) Guardio/Vesta Update Cable (1) ECG cable, 3 Leads Snap (1) Manual insert
Impulse Dynamics (usa) Inc.
Intelio Portable Programmer Unit
In Commercial Distribution

  • 00810003380067 ()
10-A701-3-XX

  • Cardiac contractility modulation system programmer
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K1
In Commercial Distribution

  • M2138063M0K15 ()

  • Total Volume: 1.5 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
LOADING SYS LS-ENVEOR-34-US COMM
MEDTRONIC COREVALVE LLC
LS-ENVEOR-34-US
In Commercial Distribution

  • 00643169640344 ()


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
DELIV SYS ENVEOR-N-US 34MM COMM
MEDTRONIC COREVALVE LLC
ENVEOR-N-US
In Commercial Distribution

  • 00643169640337 ()

  • Outer Diameter: 6.7 Millimeter
  • Length: 107.0 Centimeter


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use
Blood Glucose Test strips. 35 test strips.
ASCENSIA DIABETES CARE US INC.
7277
In Commercial Distribution

  • 40301937277359 ()
  • 00301937277351 ()
  • 10301937277358 ()
  • 00301937277016 ()
85723154

  • Glucose monitoring system IVD, home-use
SALVIN OraTAPE® Absorbable Collagen Wound Dressing for Dental Surgery, 1in x 3in
Integra Lifesciences Corporation
#ORATAPE-PKG-10
Not in Commercial Distribution

  • 30381780000338 ()
  • 10381780000334 ()
  • M268ORATAPEPKG101 ()
  • 00381780000337 ()

  • 2 1/2 cm x 7 1/2 cm
  • 1 in x 3 in
#ORATAPE-PKG-10

  • Animal-derived wound matrix dressing
SALVIN OraPLUG® Absorbable Collagen Wound Dressing, 3/8in x 3/4in
Integra Lifesciences Corporation
#ORAPLUG-PKG-10
Not in Commercial Distribution

  • 30381780000321 ()
  • 10381780000327 ()
  • M268ORAPLUGPKG101 ()
  • 00381780000320 ()

  • 1 cm x 2 cm
  • 3/8 in x 3/4 in
#ORAPLUG-PKG-10

  • General oral wound dressing, animal-derived
SALVIN OraCOTE® Absorbable Collagen Wound Dressing for Dental Surgery, 3/4in x 1 1/2in
Integra Lifesciences Corporation
#ORACOTE-PKG-10
Not in Commercial Distribution

  • 30381780000314 ()
  • 10381780000310 ()
  • M268ORACOTEPKG101 ()
  • 00381780000313 ()

  • 2 cm x 4 cm
  • 3/4 in x 1 1/2 in
#ORACOTE-PKG-10

  • Animal-derived wound matrix dressing
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