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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Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø56mm Taper Size 4
CORIN LTD
320.04.356
In Commercial Distribution

  • 05055343880630 ()
320.04.356

  • Acetabular shell
Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø54mm Taper Size 3
CORIN LTD
320.03.354
In Commercial Distribution

  • 05055343880623 ()
320.03.354

  • Acetabular shell
Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø52mm Taper Size 3
CORIN LTD
320.03.352
In Commercial Distribution

  • 05055343880616 ()
320.03.352

  • Acetabular shell
Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø58mm Taper Size 4
CORIN LTD
320.04.358
In Commercial Distribution

  • 05055343880609 ()
320.04.358

  • Acetabular shell
Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø50mm Taper Size 2
CORIN LTD
320.02.350
In Commercial Distribution

  • 05055343880265 ()
320.02.350

  • Acetabular shell
Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø44mm Taper Size 1
CORIN LTD
320.01.344
In Commercial Distribution

  • 05055343880258 ()
320.01.344

  • Acetabular shell
No Description
MAXILL, INC.
6070541528
In Commercial Distribution

  • D89260705415280 ()
  • D89260705415281 ()


  • Dental wedge, single-use
No Description
MAXILL, INC.
6070541527
In Commercial Distribution

  • D89260705415270 ()
  • D89260705415271 ()


  • Dental wedge, single-use
No Description
MAXILL, INC.
6070541526
In Commercial Distribution

  • D89260705415260 ()
  • D89260705415261 ()


  • Dental wedge, single-use
No Description
W.H. Holden, Inc.
10-5577-1S
In Commercial Distribution

  • D9281055771S0 ()


  • Dental cheek retractor, professional, reusable
Nitrile Exam Glove with Aloe, Green, X-Large
Dash Medical Gloves, Inc.
NA100XL
In Commercial Distribution

  • 00649531420774 ()
  • 00649531320777 ()
  • 00649531320074 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove with Aloe, Green, Large
Dash Medical Gloves, Inc.
NA100L
In Commercial Distribution

  • 00649531420767 ()
  • 00649531320760 ()
  • 00649531320067 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove with Aloe, Green, Medium
Dash Medical Gloves, Inc.
NA100M
In Commercial Distribution

  • 00649531420743 ()
  • 00649531320746 ()
  • 00649531320043 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Exam Glove with Aloe, Green, Small
Dash Medical Gloves, Inc.
NA100S
In Commercial Distribution

  • 00649531420729 ()
  • 00649531320722 ()
  • 00649531320029 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
OTODYNAMICS LIMITED
OS-ST+ABR
In Commercial Distribution

  • 05060396171062 ()


  • Evoked-potential audiometer
No Description
W.H. Holden, Inc.
10-4046R-SER
In Commercial Distribution

  • D928104046RSER0 ()


  • Dental elevator, tooth/root
No Description
FLEXICARE MEDICAL LIMITED
362-000-000U
In Commercial Distribution

  • 05055788792314 ()


  • Straight/elbow breathing circuit connector, single-use
No Description
BONART CO., LTD.
MS0002-412RH
In Commercial Distribution

  • 04719873121205 ()


  • Ultrasonic dental scaling/debridement system
Anesthesia Frame with Clamp (R2)
MIZUHO CORPORATION
08-060-02-R2
In Commercial Distribution

  • 04946329218411 ()

  • Length: 640.5 Millimeter
08-060-02-R2

  • Anaesthesia screen
Anesthesia Frame with Clamp (R1)
MIZUHO CORPORATION
08-060-02-R1
In Commercial Distribution

  • 04946329218404 ()

  • Length: 640.5 Millimeter
08-060-02-R1

  • Anaesthesia screen
Anesthesia Frame with Clamp
MIZUHO CORPORATION
08-060-02
In Commercial Distribution

  • 04946329067323 ()

  • Length: 640.5 Millimeter
08-060-02

  • Anaesthesia screen
No Description
Laborie Medical Technologies Canada ULC
PRO177
In Commercial Distribution

  • 00627825004275 ()


  • Evoked-potential graphic recording system
The Forceps are for use during a variety of laparoscopic procedures for cutting, grasping, coagulation & transaction of vessels & tissue.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3549ULT
In Commercial Distribution

  • 35051223005514 ()
  • 05051223005513 ()

  • 5mm diameter x 44cm length
PS3549ULT

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
The forceps are for use during a variety of laparoscopic procedures for cutting, grasping, coagulation & transaction of vessels & tissue.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3544ULT
In Commercial Distribution

  • 35051223005477 ()
  • 05051223005476 ()

  • 5mm diameter x 44cm length
PS3544ULT

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
The Forceps are for use during a variety of laparoscopic procedures for cutting, grasping, coagulation & transaction of vessels & tissue.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3534ULT
In Commercial Distribution

  • 35051223005392 ()
  • 05051223005391 ()

  • 5mm diameter x 17cm length
PS3534ULT

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Dimension® EXL with LM integrated chemistry system and Sample Transfer Module
Siemens Healthcare Diagnostics Inc.
10639337
In Commercial Distribution

  • 00630414593593 ()
778031.911

  • Multiple clinical chemistry analyser IVD, laboratory
No Description
Biomet Orthopedics, LLC
903719
In Commercial Distribution

  • 00880304405035 ()
903719

  • Bone file/rasp, manual, reusable
No Description
Biomet Orthopedics, LLC
471782
In Commercial Distribution

  • 00880304384514 ()
471782

  • Bone-resection orthopaedic reamer, reusable
No Description
Terumo Cardiovascular Systems Corporation
45053
In Commercial Distribution

  • 50699753450535 ()
  • 00699753450530 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
Terumo Cardiovascular Systems Corporation
45052
In Commercial Distribution

  • 50699753450528 ()
  • 00699753450523 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
Terumo Cardiovascular Systems Corporation
45051
In Commercial Distribution

  • 50699753450511 ()
  • 00699753450516 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
Terumo Cardiovascular Systems Corporation
45050
In Commercial Distribution

  • 50699753450504 ()
  • 00699753450509 ()


  • Cardiopulmonary bypass system blood tubing set
No Description
Double Medical Technology Inc.
110041900
In Commercial Distribution

  • 06902139110664 ()
110041900

  • Surgical implant handling forceps
No Description
Double Medical Technology Inc.
110041400
In Commercial Distribution

  • 06902139110596 ()
110041400

  • Surgical drill guide, reusable
No Description
Biomet Orthopedics, LLC
110005089
In Commercial Distribution

  • 00880304567641 ()
110005089

  • Ligament bone anchor
No Description
Biomet Orthopedics, LLC
110005087
In Commercial Distribution

  • 00880304567634 ()
110005087

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
402283
In Commercial Distribution

  • 00880304560796 ()
402283

  • Orthopaedic cement, antimicrobial
Bracket with Tube Guide
WESTMED, INC.
WP-7704
In Commercial Distribution

  • 10709078013574 ()
  • 00709078013560 ()


  • PEEP valve, single-use
No Description
Biomet Orthopedics, LLC
402439
In Commercial Distribution

  • 00880304476783 ()
402439

  • Orthopaedic cement, antimicrobial
Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000242 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
10 ml
Not in Commercial Distribution

  • 00865849000228 ()

  • Total Volume: 10 Milliliter
9515140

  • Dental coating, tooth-desensitizing
A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
DDS
Not in Commercial Distribution

  • 00865849000204 ()


  • Dental coating, tooth-desensitizing
PowerLook Density Assessment software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution

  • 00858012005656 ()
DSC012

  • Basic diagnostic x-ray system application software
The SuperPole F.R.S. (floor receptacle system) with SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole F.R.S. (a support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor). The horizontal bar can be lifted, pivoted, and lowered to the next locking position around the F.R.S. pole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole F.R.S. by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves strong enough for the SuperBar to support the user. When the SuperPole F.R.S. is removed from the concrete receptacle, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight.
Healthcraft Products Inc.
FRS-SPB
In Commercial Distribution

  • 00689281035866 ()
03596

  • Hand rail
No Description
HILL LABORATORIES CO.
Air Flex II with Auto-Distraction
In Commercial Distribution

  • 00860001452525 ()


  • Body arch traction table
No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution

  • 00860000564007 ()


  • Cognitive assessment software
A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC6150
In Commercial Distribution

  • 00850051939473 ()
ECWF100

  • First aid absorbent pad/bandage
A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC6350
In Commercial Distribution

  • 00850051939381 ()
ECWF300

  • First aid absorbent pad/bandage
blue vinyl, 22mm OD, 50/bx
Vacumed
1007-MP
In Commercial Distribution

  • 00850644007589 ()
  • 08506440075896 ()
1007-MP

  • Breathing mouthpiece, single-use
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