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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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11 x 6.5 x 1.5 wedge pad - 00856181003541

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

14 x 4 x 2 wedge pad - 00856181003503

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

FoamSTEP Rectangular 270 x 180 x 70 - 09120074394544

No Description
IT-V Medizintechnik GmbH
P10107-454
In Commercial Distribution

  • 09120074394544 ()


  • Radiological whole-body positioner

Plateau-Z 10mm x 30mm x 16mm, 0° - 00190837017934

No Description
Life Spine, Inc.
43-1030-16
In Commercial Distribution

  • 00190837017934 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 30mm x 15mm, 0° - 00190837017927

No Description
Life Spine, Inc.
43-1030-15
In Commercial Distribution

  • 00190837017927 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 30mm x 14mm, 0° - 00190837017910

No Description
Life Spine, Inc.
43-1030-14
In Commercial Distribution

  • 00190837017910 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 30mm x 13mm, 0° - 00190837017903

No Description
Life Spine, Inc.
43-1030-13
In Commercial Distribution

  • 00190837017903 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 30mm x 12mm, 0° - 00190837017897

No Description
Life Spine, Inc.
43-1030-12
In Commercial Distribution

  • 00190837017897 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 30mm x 11mm, 0° - 00190837017880

No Description
Life Spine, Inc.
43-1030-11
In Commercial Distribution

  • 00190837017880 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 30mm x 10mm, 0° - 00190837017873

No Description
Life Spine, Inc.
43-1030-10
In Commercial Distribution

  • 00190837017873 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 24mm x 16mm, 0° - 00190837017866

No Description
Life Spine, Inc.
43-1024-16
In Commercial Distribution

  • 00190837017866 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 24mm x 15mm, 0° - 00190837017859

No Description
Life Spine, Inc.
43-1024-15
In Commercial Distribution

  • 00190837017859 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 24mm x 14mm, 0° - 00190837017842

No Description
Life Spine, Inc.
43-1024-14
In Commercial Distribution

  • 00190837017842 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 24mm x 13mm, 0° - 00190837017835

No Description
Life Spine, Inc.
43-1024-13
In Commercial Distribution

  • 00190837017835 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 24mm x 12mm, 0° - 00190837017828

No Description
Life Spine, Inc.
43-1024-12
In Commercial Distribution

  • 00190837017828 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 24mm x 11mm, 0° - 00190837017811

No Description
Life Spine, Inc.
43-1024-11
In Commercial Distribution

  • 00190837017811 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 24mm x 10mm, 0° - 00190837017804

No Description
Life Spine, Inc.
43-1024-10
In Commercial Distribution

  • 00190837017804 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 28mm x 16mm, 0° - 00190837017798

No Description
Life Spine, Inc.
43-1028-16
In Commercial Distribution

  • 00190837017798 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 28mm x 15mm, 0° - 00190837017781

No Description
Life Spine, Inc.
43-1028-15
In Commercial Distribution

  • 00190837017781 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 28mm x 14mm, 0° - 00190837017774

No Description
Life Spine, Inc.
43-1028-14
In Commercial Distribution

  • 00190837017774 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 28mm x 13mm, 0° - 00190837017767

No Description
Life Spine, Inc.
43-1028-13
In Commercial Distribution

  • 00190837017767 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 28mm x 12mm, 0° - 00190837017750

No Description
Life Spine, Inc.
43-1028-12
In Commercial Distribution

  • 00190837017750 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 28mm x 11mm, 0° - 00190837017743

No Description
Life Spine, Inc.
43-1028-11
In Commercial Distribution

  • 00190837017743 ()


  • Polymeric spinal interbody fusion cage

Plateau-Z 10mm x 28mm x 10mm, 0° - 00190837017736

No Description
Life Spine, Inc.
43-1028-10
In Commercial Distribution

  • 00190837017736 ()


  • Polymeric spinal interbody fusion cage

Triangular Bandage 96cm x 96cm x 136cm - 04007418921459

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

Triangular Bandage 96cm x 96cm x 136cm - 04007418921404

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

MINI TRAY, 1.5 x 2.7 x 1.0 - 00848665024128

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9907-000
In Commercial Distribution

  • 00848665024128 ()


  • Surgical instrument/implant rack

AQUARI SURFACE 30 x 12 x 3.5 - 00842430115950

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
246-INFANT
Not in Commercial Distribution

  • 00842430115950 ()
246-INFANT

  • Operating table patient pressure distribution monitoring/regulation system

PAD, FOOTBOARD, 17 X 12 X 2 - 00842430103131

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
CT-356509420
In Commercial Distribution

  • 00842430103131 ()
CT-356509420

  • Operating table mattress, basic

PAD, WHEELCHAIR, 16" X 16" X 3" - 00842430102738

Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69461
In Commercial Distribution

  • 00842430102738 ()
69461

  • Wheelchair seat cushion

WHEELCHAIR PAD 18 X 16 X 3 - 00842430114274

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69462
In Commercial Distribution

  • 00842430114274 ()
69462

  • Wheelchair seat cushion

DOME POSITIONER, 14" X 6" X 3" - 00842430113321

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
10620
In Commercial Distribution

  • 00842430113321 ()
10620

  • Freestanding patient positioner, reusable

TABLE MAT, 3.5 X 20 X 2 - 00842430101809

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

BioStrip BioHorizons - 25mm x 75mm x 1mm - 00813909010267

Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2210
In Commercial Distribution

  • 00813909010267 ()
  • 00813909010540 ()

  • Width: 25 Millimeter
  • Depth: 1 Millimeter
  • Length: 75 Millimeter
BH2210

  • General oral wound dressing, animal-derived

Pad Stretcher 28.75 x 73.25 x 4 - B337BB7625X2875X41

FHC Stretcher Pad 28.75" x 73.25" x 4" Polyfoam Fusion Top Lectrolite Bottom with Velcro Kits
FUTURE HEALTH CONCEPTS, INC.
BB76.25X28.75X4
In Commercial Distribution

  • B337BB7625X2875X41 ()
BB76.25X28.75X4

  • Stretcher mattress

Stretcher Pad 26 X 75 X 4 - B337BB26X75X41

Stretcher Pad 26 X 75 X 4 Dura-Comfort Material Pad With 2 Rounded and 2 angled Corners With Velcro Kit
FUTURE HEALTH CONCEPTS, INC.
BB26X75X4
In Commercial Distribution

  • B337BB26X75X41 ()
BB26X75X4

  • Stretcher mattress

Stretcher Pad 26 X 74 X 3 - B337BB26X74X31

Stretcher Pad 26 X 74 X 3 With Round Corners Comfort Care Cover with Velcro Kit
FUTURE HEALTH CONCEPTS, INC.
BB26X74X3
In Commercial Distribution

  • B337BB26X74X31 ()
BB26X74X3

  • Stretcher mattress

Cervical Interbody 13mm x 12mm x 4mm - B064XM11201041

Cervical Interbody 13mm x 12mm x 4mm
XENCO MEDICAL LLC
XM-112-0104
In Commercial Distribution

  • B064XM11201041 ()


  • Spinal fixation plate, non-bioabsorbable

Cervical Interbody 17mm x 13.5mm x 12mm  - B064XM21617121

No Description
XENCO MEDICAL LLC
XM-216-1712
In Commercial Distribution

  • B064XM21617121 ()


  • Spinal fixation plate, non-bioabsorbable

Cervical Interbody 17mm x 13.5mm x 11mm  - B064XM21617111

No Description
XENCO MEDICAL LLC
XM-216-1711
In Commercial Distribution

  • B064XM21617111 ()


  • Spinal fixation plate, non-bioabsorbable
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