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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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Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid
Intera Oncology Inc.
AP-07004
In Commercial Distribution

  • 00850014110130 ()
AP07004

  • Hypodermic needle, single-use
Gastrointestinal Boundary Identification and Sizing Tube 40 French
Reshape Lifesciences Inc.
B-2040
Not in Commercial Distribution

  • 00850007764234 ()
B-2040

  • Gastric calibration tube
Gastrointestinal Boundary Identification and Sizing Tube 36 French
Reshape Lifesciences Inc.
B-2036
Not in Commercial Distribution

  • 00850007764227 ()
B-2036

  • Gastric calibration tube
Gastrointestinal Boundary Identification and Sizing Tube 32 French
Reshape Lifesciences Inc.
B-2032
Not in Commercial Distribution

  • 00850007764210 ()
B-2032

  • Gastric calibration tube
Enhance® mini Intro Kit
DENTSPLY INTERNATIONAL INC.
624385
In Commercial Distribution

  • D0026243851 ()
624385

  • Dental abrasive disk, reusable
Enhance® mini Finishing Point Refill
DENTSPLY INTERNATIONAL INC.
624365
In Commercial Distribution

  • D0026243650 ()
  • D0026243651 ()
624365

  • Dental abrasive disk, reusable
Enhance® mini Finishing Cup Refill
DENTSPLY INTERNATIONAL INC.
624355
In Commercial Distribution

  • D0026243550 ()
  • D0026243551 ()
624355

  • Dental abrasive disk, reusable
Enhance® mini Finishing Disc Refill
DENTSPLY INTERNATIONAL INC.
624345
In Commercial Distribution

  • D0026243450 ()
  • D0026243451 ()
624345

  • Dental abrasive disk, reusable
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
Global Healthcare Product Solutions, LLC
FE2311
Not in Commercial Distribution

  • 00850022724190 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
BYD CARE Single-use Face Mask Non-sterile Soft & Easy to Breath BFE >= 98% PFE >= 98% Flammability: Class I ASTM Level3 Flat Mask Specifications:175mm×95mm / 6.89in.×3.74in 10pcs/bag ×5bags
Global Healthcare Product Solutions, LLC
FE2311
Not in Commercial Distribution

  • 00850022724183 ()

  • Area/Surface Area: 25.77 Square inch
FE2311

  • Surgical/examination garment kit
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