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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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Steth IO - The Smartphone Stethoscope for iPhone 7+ or 8+
Steth IO
iPhone 7+/8+
In Commercial Distribution

  • 00860135001927 ()


  • Electronic acoustic stethoscope
Steth IO - The Smartphone Stethoscope for iPhone 7 or 8
Steth IO
iPhone 7/8
In Commercial Distribution

  • 00860135001910 ()


  • Electronic acoustic stethoscope
No Description
WORK INCORPORATED
2049
Not in Commercial Distribution

  • 00860110000303 ()


  • Enteral feeding bag/bottle
No Description
AMVENTUREX, INC.
S5800335
In Commercial Distribution

  • 00860060002334 ()


  • Ketone (acetoacetate) IVD, control
No Description
AMVENTUREX, INC.
S5640791
In Commercial Distribution

  • 00860060002327 ()


  • Ketone (acetoacetate) IVD, reagent
No Description
AMVENTUREX, INC.
s11006
In Commercial Distribution

  • 00860060002310 ()


  • Ketone (acetoacetate) IVD, kit, spectrophotometry
No Description
GLYTEC, LLC
None
In Commercial Distribution

  • 00860057000305 ()


  • Infusion pump medication-dosage application software
No Description
Color Diagnostics, LLC
1.0
In Commercial Distribution

  • 00860014139314 ()


  • General specimen container IVD, additive/medium
Buttress Support Plate (Long)
MCCONNELL ORTHOPEDIC MFG. CO.
15-150
In Commercial Distribution

  • 00860013953522 ()
15-150

  • Operating table torso positioner
Buttress Support Plate (Standard)
MCCONNELL ORTHOPEDIC MFG. CO.
15-100
In Commercial Distribution

  • 00860013953515 ()
15-100

  • Operating table torso positioner
No Description
LARONIX PTY LTD
1.0
In Commercial Distribution

  • 00860013939021 ()


  • Transcervical artificial larynx
No Description
LARONIX PTY LTD
1.0
In Commercial Distribution

  • 00860013939007 ()


  • Transcervical artificial larynx
Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
901005
In Commercial Distribution

  • 00860013905972 ()
901005

  • Orthopaedic inorganic implant inserter/extractor, single-use
  • Tendon/ligament bone anchor, non-bioabsorbable
Tendon Seam™ Magazine - 4 Anchor, included with Tendon Seam™ Instrument Kit - 4 Anchor
Integrity Orthopaedics, Inc
901001
In Commercial Distribution

  • 00860013905958 ()
901001

  • Tendon/ligament bone anchor, non-bioabsorbable
Tendon Seam™ Magazine - 8 Anchor
Integrity Orthopaedics, Inc
901002
In Commercial Distribution

  • 00860013905941 ()
901002

  • Tendon/ligament bone anchor, non-bioabsorbable
Delivery Instrument, included with Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
902001
In Commercial Distribution

  • 00860013905927 ()
902001

  • Orthopaedic inorganic implant inserter/extractor, single-use
Tendon Seam™ Magazine - 8 Anchor, included with Tendon Seam™ Instrument Kit - 8 Anchor
Integrity Orthopaedics, Inc
901001
In Commercial Distribution

  • 00860013905910 ()
901001

  • Tendon/ligament bone anchor, non-bioabsorbable
Sterile Empty EVA Pillow Bag, 5000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0500
In Commercial Distribution

  • 00860013851279 ()
  • 10860013851276 ()
IFP-17G-0500

  • Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 3000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0300
In Commercial Distribution

  • 00860013851255 ()
  • 10860013851252 ()
IFP-17G-0300

  • Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 2000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0200
In Commercial Distribution

  • 00860013851248 ()
  • 10860013851245 ()
IFP-17G-0200

  • Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 1000 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0100
In Commercial Distribution

  • 00860013851231 ()
  • 10860013851238 ()
IFP-17G-0100

  • Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 500 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0050
In Commercial Distribution

  • 00860013851224 ()
  • 10860013851221 ()
IFP-17G-0050

  • Intravenous administration bag/bottle
Sterile Empty EVA Pillow Bag, 150 mL, 3 Ports, With One LF Port
INTERNATIONAL FILTER PRODUCTS, INC.
IFP-17G-0015
In Commercial Distribution

  • 00860013851200 ()
  • 10860013851207 ()
IFP-17G-0015

  • Intravenous administration bag/bottle
NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. NxGen Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment.
SAFEY MEDICAL DEVICES PRIVATE LIMITED
165221
In Commercial Distribution

  • 00860013746414 ()

  • Weight: 300 Gram


  • Diagnostic spirometer, professional
LEVEL 2 DISPOSABLE ISOLATION GOWN - 10 PACK
Two One Two New York, Inc.
27000XL
In Commercial Distribution

  • 10860013168923 ()
  • 00860013168926 ()
  • 00860013168933 ()
27000XL

  • Isolation gown, single-use
LEVEL 2 DISPOSABLE ISOLATION GOWN-10 PACK
Two One Two New York, Inc.
27000L
In Commercial Distribution

  • 00860013168919 ()
  • 00860013168902 ()
  • 10860013168909 ()
27000L

  • Isolation gown, single-use
No Description
Boston Brace International, Inc.
SENSOR-CB-V1
In Commercial Distribution

  • 00860013109837 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
No Description
Boston Brace International, Inc.
SENSOR-WP-V1
In Commercial Distribution

  • 00860013109820 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
OPSB Sensor
Boston Brace International, Inc.
SENSOR-V1
In Commercial Distribution

  • 00860013109806 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
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