Company Name Brand Name GMDN Term 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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Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Evac cart, above the smoke evacuator
ACUDERM, INC.
CMB
In Commercial Distribution

  • 00814105020579 ()


  • Surgical plume evacuation system
Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels two of which swivel
ACUDERM, INC.
DUALCART
In Commercial Distribution

  • 00814105020562 ()


  • Surgical plume evacuation system
Wall mount bracket for mounting Acu-Evac IE-1 and Acu-Evac II to a wall
ACUDERM, INC.
EWMB
In Commercial Distribution

  • 00814105020555 ()


  • Surgical plume evacuation system
Pneumatic foot switch provides convenient ON-OFF control of Acu-Evac
ACUDERM, INC.
PFTSW
In Commercial Distribution

  • 00814105020548 ()


  • Surgical plume evacuation system
Flexible boom arm holds hose and nozzle in place for hands free operation. Not intended for use with lasers.
ACUDERM, INC.
ARM
In Commercial Distribution

  • 00814105020531 ()


  • Surgical plume evacuation system
Hose connector used to connect TX Pack or LTX Pack to hose
ACUDERM, INC.
HOSECON
In Commercial Distribution

  • 00814105020524 ()


  • Surgical plume evacuation system
6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
ACUDERM, INC.
HOSE
In Commercial Distribution

  • 00814105020517 ()


  • Surgical plume evacuation system
Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 32 hours except for erbium smoke.
ACUDERM, INC.
M2-FILTER
In Commercial Distribution

  • 00814105020487 ()


  • Surgical plume evacuation system
Consists of a charcoal/odor filter and an ULPA filter-rated 99.9997% efficiency on particles 0..01 micron and 0.12 microns MPPS. Normal use filter life: 16 hours except for erbium smoke.
ACUDERM, INC.
M1-FILTER
In Commercial Distribution

  • 00814105020470 ()


  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-230
Not in Commercial Distribution

  • 30653405059091 ()
60-8080-230

  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-120
Not in Commercial Distribution

  • 30653405059084 ()
60-8080-120

  • Surgical plume evacuation system
AER DEFENSE FILTERONE
Conmed Corporation
60-8084-001
In Commercial Distribution

  • 30653405058230 ()
  • 00653405058239 ()
  • 20653405058233 ()
60-8084-001

  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-230
In Commercial Distribution

  • 20653405059094 ()
  • 10653405059097 ()
60-8080-230

  • Surgical plume evacuation system
AER DEFENSE SMOKE EVACUATOR SYSTEM
Conmed Corporation
60-8080-120
In Commercial Distribution

  • 20653405059087 ()
  • 10653405059080 ()
60-8080-120

  • Surgical plume evacuation system
Smoke Attachment Extender
Covidien LP
E3595
In Commercial Distribution

  • 10884524001814 ()
  • 20884524001811 ()
E3595

  • Surgical plume evacuation system
Smoke Attachment
Covidien LP
E3590
In Commercial Distribution

  • 20884524000296 ()
  • 10884524000299 ()
E3590

  • Surgical plume evacuation system
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
AlboSure Vascular Patch 2x9 cm
Lemaitre Vascular, Inc.
AP20090R
In Commercial Distribution

  • 00840663105021 ()
AP20090R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 15 cm
Lemaitre Vascular, Inc.
AP10150R
In Commercial Distribution

  • 00840663104895 ()
AP10150R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 10 cm
Lemaitre Vascular, Inc.
AP10100R
In Commercial Distribution

  • 00840663104802 ()
AP10100R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 7.5 cm
Lemaitre Vascular, Inc.
AP10075T
In Commercial Distribution

  • 00840663104765 ()
AP10075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.8x 7.5 cm
Lemaitre Vascular, Inc.
AP08075T
In Commercial Distribution

  • 00840663104604 ()
AP08075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.6x 7.5 cm
Lemaitre Vascular, Inc.
AP06075T
In Commercial Distribution

  • 00840663104543 ()
AP06075T

  • Cardiovascular patch, animal-derived
4 Level, 94mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-94
In Commercial Distribution

  • 111106494 ()
  • M364111106FD4940 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 90mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-90
In Commercial Distribution

  • 111106490 ()
  • M364111106FD4900 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 86mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-86
In Commercial Distribution

  • 111106486 ()
  • M364111106FD4860 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 82mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-82
In Commercial Distribution

  • 111106482 ()
  • M364111106FD4820 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 78mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-78
In Commercial Distribution

  • 111106478 ()
  • M364111106FD4780 ()


  • Spinal fixation plate, non-bioabsorbable
4 Level, 74mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-74
In Commercial Distribution

  • 111106474 ()
  • M364111106FD4740 ()


  • Spinal fixation plate, non-bioabsorbable
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