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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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EARP INSTRUMENTS - 00810135960649

RETRACTABLE OSTEOTOME. 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-O
In Commercial Distribution

  • 00810135960649 ()


  • Orthopaedic osteotome

EARP INSTRUMENTS - 00810135960632

EARP FINAL INSERTER. 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-FI
In Commercial Distribution

  • 00810135960632 ()


  • General internal orthopaedic fixation system implantation kit

EARP INSTRUMENTS - 00810135960625

EARP INITIAL INSERTER. 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-II
In Commercial Distribution

  • 00810135960625 ()


  • General internal orthopaedic fixation system implantation kit

EARP INSTRUMENTS - 00810135960618

EARP DISC SPACER INSERTER. 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-002
In Commercial Distribution

  • 00810135960618 ()


  • General internal orthopaedic fixation system implantation kit

EARP INSTRUMENTS - 00810135960601

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 INSTRUMENTS - 00810135960595

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 INSTRUMENTS - 00810135960588

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 INSTRUMENTS - 00810135960571

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

E.M Adams co, inc. - 10840200307427

BELT
E.M. ADAMS, INC.
EP26-63391-1
In Commercial Distribution

  • 50840200307418 ()
  • 10840200307427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307403

BELT
E.M. ADAMS, INC.
EP26-63375-1
In Commercial Distribution

  • 50840200307395 ()
  • 10840200307403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
In Commercial Distribution

  • 50840200307371 ()
  • 10840200307380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307366

BELT
E.M. ADAMS, INC.
EP26-63350-1
In Commercial Distribution

  • 50840200307357 ()
  • 10840200307366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
In Commercial Distribution

  • 50840200307333 ()
  • 10840200307342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407427

BELT
E.M. ADAMS, INC.
EP26-63391-1
Not in Commercial Distribution

  • 58100013407418 ()
  • 18100013407427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407403

BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407366

BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E-Pacer - 00858101008292

Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

DeRoyal - 00749756847865

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672
In Commercial Distribution

  • 50749756847860 ()
  • 00749756847865 ()
M2672

  • Gait rehabilitation system harness

DeRoyal - 00749756846462

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2656
In Commercial Distribution

  • 00749756846462 ()
M2656

  • Gait rehabilitation system harness

DeRoyal - 00749756797900

HEAVY DUTY GAIT BELT
DEROYAL INDUSTRIES, INC.
400P10
In Commercial Distribution

  • 50749756797905 ()
  • 00749756797900 ()
400P10

  • Gait rehabilitation system harness

DeRoyal - 00749756367769

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

  • 00749756367769 ()
M5166-84

  • Gait rehabilitation system harness

DeRoyal - 00749756352833

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167-B
In Commercial Distribution

  • 50749756352838 ()
  • 00749756352833 ()
M5167-B

  • Gait rehabilitation system harness

DeRoyal - 00749756281935

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D25
In Commercial Distribution

  • 50749756281930 ()
  • 00749756281935 ()
M2616D25

  • Gait rehabilitation system harness

DeRoyal - 00749756613637

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168
In Commercial Distribution

  • 00749756613637 ()
M5168

  • Gait rehabilitation system harness

DeRoyal - 00749756242417

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D72
In Commercial Distribution

  • 50749756242412 ()
  • 00749756242417 ()
M2616D72

  • Gait rehabilitation system harness

DeRoyal - 00749756237499

Adaptor For Valleylab Optimum
DEROYAL INDUSTRIES, INC.
88-000696
In Commercial Distribution

  • 50749756237494 ()
  • 00749756237499 ()
88-000696

  • Surgical plume evacuation system

DeRoyal - 00749756232609

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D01
In Commercial Distribution

  • 00749756232609 ()
M2616D01

  • Gait rehabilitation system harness

DeRoyal - 00749756735209

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-B
In Commercial Distribution

  • 50749756735204 ()
  • 00749756735209 ()
M5166-B

  • Gait rehabilitation system harness

DeRoyal - 00749756678032

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164
In Commercial Distribution

  • 00749756678032 ()
M5164

  • Gait rehabilitation system harness

DeRoyal - 00749756677776

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5165
In Commercial Distribution

  • 00749756677776 ()
M5165

  • Gait rehabilitation system harness

DeRoyal - 00749756783286

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y
In Commercial Distribution

  • 00749756783286 ()
M5166Y

  • Gait rehabilitation system harness

DeRoyal - 00749756782616

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y-72
In Commercial Distribution

  • 00749756782616 ()
M5166Y-72

  • Gait rehabilitation system harness

DeRoyal - 00749756884440

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168-Y
In Commercial Distribution

  • 00749756884440 ()
M5168-Y

  • Gait rehabilitation system harness

DeRoyal - 00749756866309

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

DeRoyal - 00749756861274

GAIT BELT
DEROYAL INDUSTRIES, INC.
M2660
In Commercial Distribution

  • 50749756861279 ()
  • 00749756861274 ()
M2660

  • Gait rehabilitation system harness

DeRoyal - 00749756999274

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164-YL
In Commercial Distribution

  • 50749756999279 ()
  • 00749756999274 ()
M5164-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756977937

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

  • 50749756977932 ()
  • 00749756977937 ()
MK3045-UBLG

  • Gait rehabilitation system harness

DeRoyal - 00749756951784

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672-B
In Commercial Distribution

  • 50749756951789 ()
  • 00749756951784 ()
M2672-B

  • Gait rehabilitation system harness

DeRoyal - 00749756947657

GAIT BELT, WIPEABLE
DEROYAL INDUSTRIES, INC.
M5168-YL
In Commercial Distribution

  • 00749756947657 ()
M5168-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756113076

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167
In Commercial Distribution

  • 00749756113076 ()
M5167

  • Gait rehabilitation system harness

DeRoyal - 00749756113069

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-72
In Commercial Distribution

  • 50749756113064 ()
  • 00749756113069 ()
M5166-72

  • Gait rehabilitation system harness

DeRoyal - 00749756113052

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166
In Commercial Distribution

  • 50749756113057 ()
  • 00749756113052 ()
M5166

  • Gait rehabilitation system harness

DR-HO'S - 06970742221473

DR-HO's Perfect Back Rest This product is used for waist massage.Plastic injection molding into the ""S"" type, the external concave can better wrap the back of the human body, the middle part of the hemispherical origin, when the user by pressure, can be very good reaction force to the back, massage the effect.Products by the back, air cushion, fixed belt combination.
Guangzhou Xinbo Electronic Co., Ltd.
PBR-1
In Commercial Distribution

  • 06970742221473 ()


  • Back-filling orthosis

DEVEX - 10705034212470

DEVEX SYSTEM CAGE FILLER BLOCK
DEPUY SPINE, LLC
286409000
Not in Commercial Distribution

  • 10705034212470 ()
286409000

  • Bone graft packing block

D750b - 00840682138758

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry UPG
In Commercial Distribution

  • 00840682138758 ()


  • Stationary gamma camera system

D750b - 00840682138741

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Biopsy
In Commercial Distribution

  • 00840682138741 ()


  • Stationary gamma camera system

D750b - 00840682138697

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry
In Commercial Distribution

  • 00840682138697 ()


  • Stationary gamma camera system

Coral - 10889981106638

Rotation Block
SEASPINE ORTHOPEDICS CORPORATION
10-40-0330
In Commercial Distribution

  • 10889981106638 ()
10-40-0330

  • Bone graft packing block
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