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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No Description
Heine Optotechnik GmbH & Co. KG
LED
In Commercial Distribution

  • 04053755202966 ()
  • 04053755203031 ()
C-130.28.330

  • Direct ophthalmoscope
STENT SFR4-3-40-10 V01 3X40
Micro Therapeutics, Inc.
SFR4-3-40-10
In Commercial Distribution

  • 00763000367626 ()

  • Stent Diameter: 3.0 Millimeter
  • Stent Length: 40.0 Millimeter


  • Thrombectomy wire-net
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9907-000
In Commercial Distribution

  • 00848665024128 ()


  • Surgical instrument/implant rack
These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil.
NEOCOIL, LLC
54
In Commercial Distribution

  • 00856181003541 ()


  • MRI system coil, radio-frequency
These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil.
NEOCOIL, LLC
50
In Commercial Distribution

  • 00856181003503 ()


  • MRI system coil, radio-frequency
No Description
Life Spine, Inc.
43-1030-15
In Commercial Distribution

  • 00190837017927 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1030-13
In Commercial Distribution

  • 00190837017903 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1030-11
In Commercial Distribution

  • 00190837017880 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1024-16
In Commercial Distribution

  • 00190837017866 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1024-14
In Commercial Distribution

  • 00190837017842 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1024-13
In Commercial Distribution

  • 00190837017835 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1030-16
In Commercial Distribution

  • 00190837017934 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1030-14
In Commercial Distribution

  • 00190837017910 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1030-12
In Commercial Distribution

  • 00190837017897 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1030-10
In Commercial Distribution

  • 00190837017873 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1024-15
In Commercial Distribution

  • 00190837017859 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1024-12
In Commercial Distribution

  • 00190837017828 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1024-11
In Commercial Distribution

  • 00190837017811 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1024-10
In Commercial Distribution

  • 00190837017804 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1028-16
In Commercial Distribution

  • 00190837017798 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1028-15
In Commercial Distribution

  • 00190837017781 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1028-14
In Commercial Distribution

  • 00190837017774 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1028-13
In Commercial Distribution

  • 00190837017767 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1028-12
In Commercial Distribution

  • 00190837017750 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1028-11
In Commercial Distribution

  • 00190837017743 ()


  • Polymeric spinal interbody fusion cage
No Description
Life Spine, Inc.
43-1028-10
In Commercial Distribution

  • 00190837017736 ()


  • Polymeric spinal interbody fusion cage
A non-sterile fabric and foam composite material in the form of a thick band intended to be used to produce a custom-made, figure-of-eight shaped arm sling. Suitable lengths are cut, typically from a roll or a dispenser box, and plastic clips used to fashion two loops, one for round the neck and the other for round a wrist (collar and cuff), to provide support for the arm. It consists of a foam core with a fabric covering and is typically used to immobilize forearm, elbow, humerus or shoulder injuries. This is a single-use device.
Hans Hepp GmbH & Co. KG
92145
In Commercial Distribution

  • 04007418921459 ()


  • Collar and cuff arm sling material
A non-sterile fabric and foam composite material in the form of a thick band intended to be used to produce a custom-made, figure-of-eight shaped arm sling. Suitable lengths are cut, typically from a roll or a dispenser box, and plastic clips used to fashion two loops, one for round the neck and the other for round a wrist (collar and cuff), to provide support for the arm. It consists of a foam core with a fabric covering and is typically used to immobilize forearm, elbow, humerus or shoulder injuries. This is a single-use device.
Hans Hepp GmbH & Co. KG
92140
In Commercial Distribution

  • 04007418921404 ()


  • Collar and cuff arm sling material
No Description
IT-V Medizintechnik GmbH
P10107-454
In Commercial Distribution

  • 09120074394544 ()


  • Radiological whole-body positioner
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
246-INFANT
Not in Commercial Distribution

  • 00842430115950 ()
246-INFANT

  • Operating table patient pressure distribution monitoring/regulation system
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
CT-356509420
In Commercial Distribution

  • 00842430103131 ()
CT-356509420

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69461
In Commercial Distribution

  • 00842430102738 ()
69461

  • Wheelchair seat cushion
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69462
In Commercial Distribution

  • 00842430114274 ()
69462

  • Wheelchair seat cushion
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
10620
In Commercial Distribution

  • 00842430113321 ()
10620

  • Freestanding patient positioner, reusable
This pad is a component of the 5848 Pelvic Reconstruction Kit. Dimensions: 20x3.5x2 inches. Made with Tempur-Pedic® Medical materials
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5847-7220
In Commercial Distribution

  • 00842430101809 ()
5847-7220

  • Operating table mattress, basic
No Description
XENCO MEDICAL LLC
XM-216-1712
In Commercial Distribution

  • B064XM21617121 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1711
In Commercial Distribution

  • B064XM21617111 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1710
In Commercial Distribution

  • B064XM21617101 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1709
In Commercial Distribution

  • B064XM21617091 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1708
In Commercial Distribution

  • B064XM21617081 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1707
In Commercial Distribution

  • B064XM21617071 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1706
In Commercial Distribution

  • B064XM21617061 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1705
In Commercial Distribution

  • B064XM21617051 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1704
In Commercial Distribution

  • B064XM21617041 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1512
In Commercial Distribution

  • B064XM21615121 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1511
In Commercial Distribution

  • B064XM21615111 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1510
In Commercial Distribution

  • B064XM21615101 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1509
In Commercial Distribution

  • B064XM21615091 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1508
In Commercial Distribution

  • B064XM21615081 ()


  • Spinal fixation plate, non-bioabsorbable
No Description
XENCO MEDICAL LLC
XM-216-1507
In Commercial Distribution

  • B064XM21615071 ()


  • Spinal fixation plate, non-bioabsorbable
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