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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 - 00810135960779

EARP, TRIAL 14X25X08 0° 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-T-1425-0008
In Commercial Distribution

  • 00810135960779 ()

  • Height: 8 Millimeter
  • Width: 25 Millimeter
  • Depth: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit

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. - 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. - 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. - 18100013407342

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

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E-Z LINK - 10614559104460

E-Z LINK
MEGADYNE MEDICAL PRODUCTS, INC.
MGEZLINK01
In Commercial Distribution

  • 10614559104460 ()
MGEZLINK01

  • Surgical plume evacuation system

E-Pacer - 00858101008292

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

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

Drive Headstage - 07290114061520

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive Headstage
In Commercial Distribution

  • 07290114061520 ()
700-006000-00

  • Depth electrode

Discovery NMCT 670 CZT - 00840682121446

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906AB
In Commercial Distribution

  • 00840682121446 ()


  • Stationary gamma camera system
  • Full-body CT system

Discovery NM 530c - 00840682105286

UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera system

Discovery 670 PRO - 00840682121194

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AH
In Commercial Distribution

  • 00840682121194 ()


  • Full-body CT system
  • Stationary gamma camera system

Discovery 670 ES - 00840682121187

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100AG
In Commercial Distribution

  • 00840682121187 ()


  • Stationary gamma camera system
  • Full-body CT system

Discovery 630 - 00840682115292

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution

  • 00840682115292 ()


  • Stationary gamma camera system

Discovery - 00840682139403

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 ES
In Commercial Distribution

  • 00840682139403 ()


  • Full-body CT system
  • Stationary gamma camera system

Discovery - 00840682139380

D670 CZT GANTRY 7.25mm WITH NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 CZT
In Commercial Distribution

  • 00840682139380 ()


  • Full-body CT system
  • Stationary gamma camera system

Discovery - 00840682139373

D670 PRO NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 PRO
In Commercial Distribution

  • 00840682139373 ()


  • Stationary gamma camera system
  • Full-body CT system

Discovery - 00840682139359

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

  • 00840682139359 ()


  • Stationary gamma camera system
  • Full-body CT system

Discovery - 00840682139274

D630 NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution

  • 00840682139274 ()


  • Stationary gamma camera system

Discovery - 00840682124393

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

  • 00840682124393 ()


  • Stationary gamma camera system
  • Full-body CT system

Discovery - 00840682123877

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 ES
In Commercial Distribution

  • 00840682123877 ()


  • Full-body CT system
  • Stationary gamma camera system

Discovery - 00840682123853

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NMCT 670 CZT
In Commercial Distribution

  • 00840682123853 ()


  • Full-body CT system
  • Stationary gamma camera system

Depthalon - 00650551144403

Depthalon Electrode, Platinum, Non-sterile, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003-NS
In Commercial Distribution

  • 00650551144403 ()


  • Depth electrode

Delasco SaftEvac - 00609960000664

Smoke Evacuator Unit and one filter pack, 220 Volt. Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
EV/2
In Commercial Distribution

  • 00609960000664 ()
EV/2

  • Surgical plume evacuation system

Delasco SaftEvac - 00609960000657

Smoke Evacuator Unit and one filter pack, 110 Volt. Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted
DERMATOLOGIC LAB AND SUPPLY, INC.
EV
In Commercial Distribution

  • 00609960000657 ()
EV

  • Surgical plume evacuation system

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
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