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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CKS, Tibial Baseplate, Holed, TiNbN Coating, Left, Size 0
Shalby Advanced Technologies, Inc.
2289-0-0000
In Commercial Distribution

  • 00840286851671 ()
2289-0-0000

  • Uncoated knee tibia prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 6
Shalby Advanced Technologies, Inc.
2268-0-0006
In Commercial Distribution

  • 00840286851664 ()
2268-0-0006

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 5
Shalby Advanced Technologies, Inc.
2268-0-0005
In Commercial Distribution

  • 00840286851657 ()
2268-0-0005

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 4
Shalby Advanced Technologies, Inc.
2268-0-0004
In Commercial Distribution

  • 00840286851640 ()
2268-0-0004

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 3
Shalby Advanced Technologies, Inc.
2268-0-0003
In Commercial Distribution

  • 00840286851633 ()
2268-0-0003

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Right, Size 2
Shalby Advanced Technologies, Inc.
2268-0-0002
In Commercial Distribution

  • 00840286851626 ()
2268-0-0002

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 6
Shalby Advanced Technologies, Inc.
2267-0-0006
In Commercial Distribution

  • 00840286851602 ()
2267-0-0006

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 4
Shalby Advanced Technologies, Inc.
2267-0-0004
In Commercial Distribution

  • 00840286851589 ()
2267-0-0004

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 3
Shalby Advanced Technologies, Inc.
2267-0-0003
In Commercial Distribution

  • 00840286851572 ()
2267-0-0003

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 2
Shalby Advanced Technologies, Inc.
2267-0-0002
In Commercial Distribution

  • 00840286851565 ()
2267-0-0002

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 1
Shalby Advanced Technologies, Inc.
2267-0-0001
In Commercial Distribution

  • 00840286851558 ()
2267-0-0001

  • Uncoated knee femur prosthesis, metallic
Content: 1 piece Height: 16 mm Sinternit (cobalt-chrome alloy) especially conceived for the production of dowels. Veneering with ceramic possible.
ZIRKONZAHN SRL
MEAU98S16
In Commercial Distribution

  • D800MEAU98S16 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 18 mm Cobalt-chrome alloy for the production of metal structures for veneering with ceramic. Info: our Chrom-Cobalt has a new name: Cocronit Superior. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAR98S18
In Commercial Distribution

  • D800MEAR98S18 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 16 mm Cobalt-chrome alloy for the production of metal structures for veneering with ceramic. Info: our Chrom-Cobalt has a new name: Cocronit Superior. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAR98S16
In Commercial Distribution

  • D800MEAR98S16 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 14 mm Cobalt-chrome alloy for the production of metal structures for veneering with ceramic. Info: our Chrom-Cobalt has a new name: Cocronit Superior. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAR98S14
In Commercial Distribution

  • D800MEAR98S14 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 12 mm Cobalt-chrome alloy for the production of metal structures for veneering with ceramic. Info: our Chrom-Cobalt has a new name: Cocronit Superior. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAR98S12
In Commercial Distribution

  • D800MEAR98S12 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 18 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S18
In Commercial Distribution

  • D800MEAL98S18 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 14 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S14
In Commercial Distribution

  • D800MEAL98S14 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 18 mm Sinternit (cobalt-chrome alloy) especially conceived for the production of dowels. Veneering with ceramic possible.
ZIRKONZAHN SRL
MEAU98S18
In Commercial Distribution

  • D800MEAU98S18 ()


  • Dental bridge, metal-ceramic
Content: 1 piece Height: 16 mm High-quality medical titanium alloy (Ti-6Al-4V ELI according to ASTM F136 and ISO 5832-3) for the production of metal structures for veneering with ceramic as well as bars and implant constructions. Info: our Titan has a new name: Titanit. Properties and range of applications remain unchanged.
ZIRKONZAHN SRL
MEAL98S16
In Commercial Distribution

  • D800MEAL98S16 ()


  • Dental bridge, metal-ceramic
134 in. (340 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFE
Not in Commercial Distribution

  • 00818666020221 ()
  • 10818666020228 ()


  • Electric infusion pump administration set, single-use
105 in. (270 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-164XESF
Not in Commercial Distribution

  • 00818666020214 ()
  • 10818666020211 ()


  • Electric infusion pump administration set, single-use
85 in. (220 cm) Microset with Filter - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XESF
Not in Commercial Distribution

  • 10818666020198 ()
  • 00818666020191 ()


  • Electric infusion pump administration set, single-use
110 in. (280 cm) Microset with Filter - Blue Stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-160XSFK
Not in Commercial Distribution

  • 10818666020013 ()
  • 00818666020016 ()


  • Electric infusion pump administration set, single-use
110 in. (280 cm) - blue stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A120-112XSFK
Not in Commercial Distribution

  • 00818666020009 ()
  • 10818666020006 ()


  • Electric infusion pump administration set, single-use
One of the most physically and mentally challenging situations an individual can face is casualty evacuation. Casualties must be moved quickly and safely. Every second wasted decreases the casualty's chance of a speedy recovery. The tactical Foxtrot® Litter carrier provides an effective casualty evacuation platform that is quick and easy to employ and compact enough to accompany individuals on a military assault or long movement. The Foxtrot® Litter from Tactical Medical Solutions is small enough to attach to your kit or another bag, but is still functional in a combat or rescue environment. It provides a rapid means of casualty movement without compromising durability, flexibility, or the individual's ability to maneuver through the most demanding environments. Casualties can be dragged or carried off target without excess time spent rigging and securing. It also eliminates the wait time for a conventional medical litter to be brought from the breach point or a support vehicle. Features: Light and compact (4.6 lbs with carrier) Size allows movement of casualties through narrow passages and walkways such as on aircraft, buses, and trains Casualties can be sat up to make tight turns on stairwells and hallways Rapid deployment drag line already rigged to litter Multiple grab points ease passage through tight areas Quick secure straps Casualty is secure but accessible for reassessments and care Can be dragged or carried
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution

  • 00818630014584 ()
F-LITC-OD

  • Portable stretcher
One of the most physically and mentally challenging situations an individual can face is casualty evacuation. Casualties must be moved quickly and safely. Every second wasted decreases the casualty's chance of a speedy recovery. The tactical Foxtrot® Litter carrier provides an effective casualty evacuation platform that is quick and easy to employ and compact enough to accompany individuals on a military assault or long movement. The Foxtrot® Litter from Tactical Medical Solutions is small enough to attach to your kit or another bag, but is still functional in a combat or rescue environment. It provides a rapid means of casualty movement without compromising durability, flexibility, or the individual's ability to maneuver through the most demanding environments. Casualties can be dragged or carried off target without excess time spent rigging and securing. It also eliminates the wait time for a conventional medical litter to be brought from the breach point or a support vehicle. Features: Light and compact (4.6 lbs with carrier) Size allows movement of casualties through narrow passages and walkways such as on aircraft, buses, and trains Casualties can be sat up to make tight turns on stairwells and hallways Rapid deployment drag line already rigged to litter Multiple grab points ease passage through tight areas Quick secure straps Casualty is secure but accessible for reassessments and care Can be dragged or carried
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution

  • 00818630014515 ()
F-LITC-R

  • Portable stretcher
One of the most physically and mentally challenging situations an individual can face is casualty evacuation. Casualties must be moved quickly and safely. Every second wasted decreases the casualty's chance of a speedy recovery. The tactical Foxtrot® Litter carrier provides an effective casualty evacuation platform that is quick and easy to employ and compact enough to accompany individuals on a military assault or long movement. The Foxtrot® Litter from Tactical Medical Solutions is small enough to attach to your kit or another bag, but is still functional in a combat or rescue environment. It provides a rapid means of casualty movement without compromising durability, flexibility, or the individual's ability to maneuver through the most demanding environments. Casualties can be dragged or carried off target without excess time spent rigging and securing. It also eliminates the wait time for a conventional medical litter to be brought from the breach point or a support vehicle. Features: Light and compact (4.6 lbs with carrier) Size allows movement of casualties through narrow passages and walkways such as on aircraft, buses, and trains Casualties can be sat up to make tight turns on stairwells and hallways Rapid deployment drag line already rigged to litter Multiple grab points ease passage through tight areas Quick secure straps Casualty is secure but accessible for reassessments and care Can be dragged or carried
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution

  • 00818630014508 ()
F-LITC-RO

  • Portable stretcher
One of the most physically and mentally challenging situations an individual can face is casualty evacuation. Casualties must be moved quickly and safely. Every second wasted decreases the casualty's chance of a speedy recovery. The tactical Foxtrot® Litter carrier provides an effective casualty evacuation platform that is quick and easy to employ and compact enough to accompany individuals on a military assault or long movement. The Foxtrot® Litter from Tactical Medical Solutions is small enough to attach to your kit or another bag, but is still functional in a combat or rescue environment. It provides a rapid means of casualty movement without compromising durability, flexibility, or the individual's ability to maneuver through the most demanding environments. Casualties can be dragged or carried off target without excess time spent rigging and securing. It also eliminates the wait time for a conventional medical litter to be brought from the breach point or a support vehicle. Features: Light and compact (4.6 lbs with carrier) Size allows movement of casualties through narrow passages and walkways such as on aircraft, buses, and trains Casualties can be sat up to make tight turns on stairwells and hallways Rapid deployment drag line already rigged to litter Multiple grab points ease passage through tight areas Quick secure straps Casualty is secure but accessible for reassessments and care Can be dragged or carried
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution

  • 00818630010555 ()
F-LITC-T

  • Portable stretcher
One of the most physically and mentally challenging situations an individual can face is casualty evacuation. Casualties must be moved quickly and safely. Every second wasted decreases the casualty's chance of a speedy recovery. The tactical Foxtrot® Litter carrier provides an effective casualty evacuation platform that is quick and easy to employ and compact enough to accompany individuals on a military assault or long movement. The Foxtrot® Litter from Tactical Medical Solutions is small enough to attach to your kit or another bag, but is still functional in a combat or rescue environment. It provides a rapid means of casualty movement without compromising durability, flexibility, or the individual's ability to maneuver through the most demanding environments. Casualties can be dragged or carried off target without excess time spent rigging and securing. It also eliminates the wait time for a conventional medical litter to be brought from the breach point or a support vehicle. Features: Light and compact (4.6 lbs with carrier) Size allows movement of casualties through narrow passages and walkways such as on aircraft, buses, and trains Casualties can be sat up to make tight turns on stairwells and hallways Rapid deployment drag line already rigged to litter Multiple grab points ease passage through tight areas Quick secure straps Casualty is secure but accessible for reassessments and care Can be dragged or carried
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution

  • 00818630010531 ()
F-LITC-B

  • Portable stretcher
One of the most physically and mentally challenging situations an individual can face is casualty evacuation. Casualties must be moved quickly and safely. Every second wasted decreases the casualty's chance of a speedy recovery. The tactical Foxtrot® Litter carrier provides an effective casualty evacuation platform that is quick and easy to employ and compact enough to accompany individuals on a military assault or long movement. The Foxtrot® Litter from Tactical Medical Solutions is small enough to attach to your kit or another bag, but is still functional in a combat or rescue environment. It provides a rapid means of casualty movement without compromising durability, flexibility, or the individual's ability to maneuver through the most demanding environments. Casualties can be dragged or carried off target without excess time spent rigging and securing. It also eliminates the wait time for a conventional medical litter to be brought from the breach point or a support vehicle. Features: Light and compact (4.6 lbs with carrier) Size allows movement of casualties through narrow passages and walkways such as on aircraft, buses, and trains Casualties can be sat up to make tight turns on stairwells and hallways Rapid deployment drag line already rigged to litter Multiple grab points ease passage through tight areas Quick secure straps Casualty is secure but accessible for reassessments and care Can be dragged or carried
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution

  • 00818630010524 ()
F-LITC-A

  • Portable stretcher
UV Spectacle Kit with Readers
RXSIGHT, INC.
62022
In Commercial Distribution

  • 00818806020876 ()


  • Tinted non-prescription spectacle lens
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23Gx1
Sol-Millennium Medical, Inc.
32310SN
In Commercial Distribution

  • 20818392019043 ()
  • 10818392019046 ()
  • 00818392019049 ()

  • Length: 25 Millimeter
  • Needle Gauge: 23 Gauge


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22Gx1 1/2
Sol-Millennium Medical, Inc.
32215SN
In Commercial Distribution

  • 10818392019039 ()
  • 00818392019032 ()
  • 20818392019036 ()

  • Length: 40 Millimeter
  • Needle Gauge: 22 Gauge


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30Gx1/2
Sol-Millennium Medical, Inc.
13005SN
In Commercial Distribution

  • 20818392018978 ()
  • 10818392018971 ()
  • 00818392018974 ()

  • Length: 12.5 Millimeter
  • Needle Gauge: 30 Gauge


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25Gx5/8
Sol-Millennium Medical, Inc.
32558SN
In Commercial Distribution

  • 20818392019074 ()
  • 10818392019077 ()
  • 00818392019070 ()

  • Length: 16 Millimeter
  • Needle Gauge: 25 Gauge


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25Gx1
Sol-Millennium Medical, Inc.
32510SN
In Commercial Distribution

  • 10818392019060 ()
  • 00818392019063 ()
  • 20818392019067 ()

  • Length: 25 Millimeter
  • Needle Gauge: 25 Gauge


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21Gx1
Sol-Millennium Medical, Inc.
32110SN
In Commercial Distribution

  • 20818392019005 ()
  • 10818392019008 ()
  • 00818392019001 ()

  • Length: 25 Millimeter
  • Needle Gauge: 21 Gauge


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27Gx1/2
Sol-Millennium Medical, Inc.
12705SN
In Commercial Distribution

  • 20818392018961 ()
  • 10818392018964 ()
  • 00818392018967 ()

  • Length: 12.5 Millimeter
  • Needle Gauge: 27 Gauge


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25Gx5/8
Sol-Millennium Medical, Inc.
12558SN
In Commercial Distribution

  • 20818392018954 ()
  • 10818392018957 ()
  • 00818392018950 ()

  • Needle Gauge: 25 Gauge
  • Length: 16 Millimeter


  • General-purpose syringe, single-use
  • Hypodermic needle, single-use
TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator
ALLWIN MEDICAL DEVICES, INC.
TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator
In Commercial Distribution

  • 10819374021859 ()
  • 00819374021852 ()
TPEB-ETC-SB

  • Assisted reproduction transfer catheter/set
PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet
ALLWIN MEDICAL DEVICES, INC.
Pro Embryo Trans with Stylet
In Commercial Distribution

  • 10819374020265 ()
  • 00819374020268 ()
PEB-ETC-STY

  • Assisted reproduction transfer catheter/set
MicroPort Smart Spot (IMV2+) / CPR4BR adapter
MICROPORT CRM SRL
KC861
In Commercial Distribution

  • 08031527018089 ()
KC861

  • Medical networking interface unit
12-(12ml) Sperm Wash Modified HTF Medium w/Gentamicin
VITROLIFE INC.
15262
In Commercial Distribution

  • 10805360016855 ()
  • 00805360016858 ()

  • Total Volume: 12 Milliliter


  • Spermatozoa/semen motility medium supplement
23ga Aspirator with Capsule Polisher
KATALYST SURGICAL LLC
1500-23
In Commercial Distribution

  • 00840096205831 ()


  • Ophthalmic working-channel cannula, reusable
23ga Irrigator With Iris Manipulator
KATALYST SURGICAL LLC
1400-23
In Commercial Distribution

  • 00840096205817 ()


  • Ophthalmic working-channel cannula, reusable
Mendez Degree Gauge With Fixation
AURORA SURGICAL, LLC
AS1-355
In Commercial Distribution

  • 08175700105583 ()
AS1-355

  • Eyeball fixation instrument, reusable
Ernest Nucleus Cracker, with Serrations
AURORA SURGICAL, LLC
AS9-001
In Commercial Distribution

  • 08175700137003 ()
AS9-001

  • Eye muscle hook, reusable
Shephard IOL Forceps With Lock
AURORA SURGICAL, LLC
AS7-652
In Commercial Distribution

  • 08175700132145 ()
AS7-652

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Vial spike with needle-free valve, pack of 10
ORIGEN BIOMEDICAL, INC.
VSV
In Commercial Distribution

  • 20816203020288 ()
  • 10816203020281 ()


  • Blood transfer set
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