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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EARP DISC SPACER 14MM The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DS-001-14
In Commercial Distribution

  • 00810135960601 ()


  • General internal orthopaedic fixation system implantation kit
EARP DISC SPACER 12MM The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DS-001-12
In Commercial Distribution

  • 00810135960595 ()


  • General internal orthopaedic fixation system implantation kit
EARP DISC SPACER 10MM The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DS-001-10
In Commercial Distribution

  • 00810135960588 ()


  • General internal orthopaedic fixation system implantation kit
EARP DISC SPACER 8MM The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DS-001-08
In Commercial Distribution

  • 00810135960571 ()


  • General internal orthopaedic fixation system implantation kit
BELT
E.M. ADAMS, INC.
EP26-63391-1
In Commercial Distribution

  • 50840200307418 ()
  • 10840200307427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63375-1
In Commercial Distribution

  • 50840200307395 ()
  • 10840200307403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63350XL-1
In Commercial Distribution

  • 50840200307371 ()
  • 10840200307380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63350-1
In Commercial Distribution

  • 50840200307357 ()
  • 10840200307366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63340XL-1
In Commercial Distribution

  • 50840200307333 ()
  • 10840200307342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63391-1
Not in Commercial Distribution

  • 58100013407418 ()
  • 18100013407427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness
Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker
HEAVY DUTY GAIT BELT
DEROYAL INDUSTRIES, INC.
400P10
In Commercial Distribution

  • 50749756797905 ()
  • 00749756797900 ()
400P10

  • Gait rehabilitation system harness
Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168-Y
In Commercial Distribution

  • 00749756884440 ()
M5168-Y

  • Gait rehabilitation system harness
Gait Belt, Heavy DutyTiger Teeth Buckle, 2 In X 70 In
DEROYAL INDUSTRIES, INC.
M2572
In Commercial Distribution

  • 50749756866304 ()
  • 00749756866309 ()
M2572

  • Gait rehabilitation system harness
GAIT BELT
DEROYAL INDUSTRIES, INC.
M2660
In Commercial Distribution

  • 50749756861279 ()
  • 00749756861274 ()
M2660

  • Gait rehabilitation system harness
GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672
In Commercial Distribution

  • 50749756847860 ()
  • 00749756847865 ()
M2672

  • Gait rehabilitation system harness
GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2656
In Commercial Distribution

  • 00749756846462 ()
M2656

  • Gait rehabilitation system harness
Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164-YL
In Commercial Distribution

  • 50749756999279 ()
  • 00749756999274 ()
M5164-YL

  • Gait rehabilitation system harness
Kit W/Blanket and Gait Belt
DEROYAL INDUSTRIES, INC.
MK3045-UBLG
In Commercial Distribution

  • 50749756977932 ()
  • 00749756977937 ()
MK3045-UBLG

  • Gait rehabilitation system harness
GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672-B
In Commercial Distribution

  • 50749756951789 ()
  • 00749756951784 ()
M2672-B

  • Gait rehabilitation system harness
GAIT BELT, WIPEABLE
DEROYAL INDUSTRIES, INC.
M5168-YL
In Commercial Distribution

  • 00749756947657 ()
M5168-YL

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-B
In Commercial Distribution

  • 50749756735204 ()
  • 00749756735209 ()
M5166-B

  • Gait rehabilitation system harness
Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164
In Commercial Distribution

  • 00749756678032 ()
M5164

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5165
In Commercial Distribution

  • 00749756677776 ()
M5165

  • Gait rehabilitation system harness
Bariatric Heavy Duty Gait Belt
DEROYAL INDUSTRIES, INC.
M5166-84
In Commercial Distribution

  • 00749756367769 ()
M5166-84

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167-B
In Commercial Distribution

  • 50749756352838 ()
  • 00749756352833 ()
M5167-B

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D25
In Commercial Distribution

  • 50749756281930 ()
  • 00749756281935 ()
M2616D25

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D72
In Commercial Distribution

  • 50749756242412 ()
  • 00749756242417 ()
M2616D72

  • Gait rehabilitation system harness
Adaptor For Valleylab Optimum
DEROYAL INDUSTRIES, INC.
88-000696
In Commercial Distribution

  • 50749756237494 ()
  • 00749756237499 ()
88-000696

  • Surgical plume evacuation system
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D01
In Commercial Distribution

  • 00749756232609 ()
M2616D01

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y
In Commercial Distribution

  • 00749756783286 ()
M5166Y

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y-72
In Commercial Distribution

  • 00749756782616 ()
M5166Y-72

  • Gait rehabilitation system harness
Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168
In Commercial Distribution

  • 00749756613637 ()
M5168

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167
In Commercial Distribution

  • 00749756113076 ()
M5167

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-72
In Commercial Distribution

  • 50749756113064 ()
  • 00749756113069 ()
M5166-72

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166
In Commercial Distribution

  • 50749756113057 ()
  • 00749756113052 ()
M5166

  • Gait rehabilitation system harness
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