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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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CONTOUR® NEXT - 10301937309509

Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7309
In Commercial Distribution

  • 40301937357501 ()
  • 00301937309502 ()
  • 10301937309509 ()
  • 40301937309500 ()
  • 0193-7309-50 ()
  • 00301937309014 ()
83623080

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 10301937308502

Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7308
Not in Commercial Distribution

  • 40301937308503 ()
  • 00301937308505 ()
  • 10301937308502 ()
  • 0193-7308-50 ()
  • 00301937308017 ()
83623064

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 10301937278706

Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
ASCENSIA DIABETES CARE US INC.
7278
In Commercial Distribution

  • 40301937278707 ()
  • 00301937278709 ()
  • 10301937278706 ()
  • 00301937278013 ()
85701231

  • Glucose monitoring system IVD, home-use

CONTOUR® NEXT - 10301937277358

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

ReShape™ Removal Catheter - B001RSM2101

ReShape™ Removal Catheter - component to remove the ReShape™ Integrated Dual Balloon
RESHAPE MEDICAL, INC.
RSM210
Not in Commercial Distribution

  • B001RSM2101 ()
RSM210

  • Flexible endoscopic biopsy handpiece/needle

Axonics - 10810005340196

Foramen Needle - Long
AXONICS MODULATION TECHNOLOGIES, INC.
9001-L
In Commercial Distribution

  • 10810005340196 ()
  • 00810005340199 ()
9001-L

  • Electrical impedance navigation spinal needle

Axonics - 10810005340189

Foramen Needle - Short
AXONICS MODULATION TECHNOLOGIES, INC.
9001-S
In Commercial Distribution

  • 10810005340189 ()
  • 00810005340182 ()
9001-S

  • Electrical impedance navigation spinal needle

PEMF - PHYSIO-STIM - 18257200136001

5315CMD, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CM
Orthofix US LLC
655315-0006
In Commercial Distribution

  • 18257200136001 ()
5315CMD

  • Flexible video laryngoscope

PEMF - PHYSIO-STIM - 18257200135998

5315CED, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, CE
Orthofix US LLC
655315-0004
In Commercial Distribution

  • 18257200135998 ()
5315CED

  • Flexible video laryngoscope

PEMF - PHYSIO-STIM - 18257200135981

5315D, DEMO, BONE GROWTH STIMULATOR, PHYSIOSTIM, US
Orthofix US LLC
655315-0002
In Commercial Distribution

  • 18257200135981 ()
5315D

  • Flexible video laryngoscope
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