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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Shrouded Quad Extension Cable, Black, Reusable
ACCESS POINT TECHNOLOGIES, INC.
901950
In Commercial Distribution

  • 00818087020329 ()

  • Length: 150 Centimeter
901950

  • Electrocardiographic lead/catheter adaptor
Shrouded Deca Extension Cable, Fixed 20 pole, Black, Reusable
ACCESS POINT TECHNOLOGIES, INC.
901957
In Commercial Distribution

  • 00818087020305 ()

  • Length: 210 Centimeter
901957

  • Electrocardiographic lead/catheter adaptor
Shrouded Deca Extension Cable, Steerable 10 pole, Black, Reusable
ACCESS POINT TECHNOLOGIES, INC.
901956
In Commercial Distribution

  • 00818087020299 ()

  • Length: 150 Centimeter
901956

  • Electrocardiographic lead/catheter adaptor
Among tourniquet brands, the SOF® Tactical Tourniquet is one of the top performing medical tourniquets currently available. It is the tourniquet of choice for many of the world's most elite and experienced warriors who have selected it for its outstanding ability to control severe bleeding, high level of reliability and ease of application. While some military units have replaced their issued tourniquets with the SOF®TT, other military units (including special forces) have implemented SOP's stating that the SOF® Tactical Tourniquet is to be used on all lower extremity bleeds. That means the SOF®TT is the tourniquet trusted to control the most severe extremity hemorrhage on the battlefield. The key to successful implementation of a device to be used in a high stress environment is training and ease of use. For law enforcement officers, application of the tourniquet is similar to the use of a hobble. This existing level of familiarity reduces training time and aids in the effectiveness of the device. ADVANTAGES OF THE SOF® TACTICAL TOURNIQUET 100% Effective. Proven to be 100% effective during US Army Institute of Surgical Research testing. Simple application. Unlike other tactical medical tourniquets that require you to learn two methods of application and implement the proper method when under stress, the SOF®TT is applied the same way to an arm or leg. By accounting for the factors of human performance in combat, we have minimized the risk of failure. Applying a tourniquet should not be a multiple choice exam; It should be simple and straight forward. The SOF®TT provides the necessary effectiveness with an unmatched level of simplicity to increase the overall effectiveness of the device. Durability. The SOF®TT is constructed of quality, high-strength materials. The special forces tourniquet handle is machined from a solid piece of aircraft aluminum and maintains its strength in extreme temperatures. The tri-rings are molded Acetyl, a high impact plastic tha
TACTICAL MEDICAL SOLUTIONS, LLC
2
In Commercial Distribution

  • 00818630012214 ()
SOFTT-NH-T

  • Limb tourniquet, manual, single-use
Among tourniquet brands, the SOF® Tactical Tourniquet is one of the top performing medical tourniquets currently available. It is the tourniquet of choice for many of the world's most elite and experienced warriors who have selected it for its outstanding ability to control severe bleeding, high level of reliability and ease of application. While some military units have replaced their issued tourniquets with the SOF®TT, other military units (including special forces) have implemented SOP's stating that the SOF® Tactical Tourniquet is to be used on all lower extremity bleeds. That means the SOF®TT is the tourniquet trusted to control the most severe extremity hemorrhage on the battlefield. The key to successful implementation of a device to be used in a high stress environment is training and ease of use. For law enforcement officers, application of the tourniquet is similar to the use of a hobble. This existing level of familiarity reduces training time and aids in the effectiveness of the device. ADVANTAGES OF THE SOF® TACTICAL TOURNIQUET 100% Effective. Proven to be 100% effective during US Army Institute of Surgical Research testing. Simple application. Unlike other tactical medical tourniquets that require you to learn two methods of application and implement the proper method when under stress, the SOF®TT is applied the same way to an arm or leg. By accounting for the factors of human performance in combat, we have minimized the risk of failure. Applying a tourniquet should not be a multiple choice exam; It should be simple and straight forward. The SOF®TT provides the necessary effectiveness with an unmatched level of simplicity to increase the overall effectiveness of the device. Durability. The SOF®TT is constructed of quality, high-strength materials. The special forces tourniquet handle is machined from a solid piece of aircraft aluminum and maintains its strength in extreme temperatures. The tri-rings are molded Acetyl, a high impact plastic tha
TACTICAL MEDICAL SOLUTIONS, LLC
2
In Commercial Distribution

  • 00818630011545 ()
SOFTT-R

  • Limb tourniquet, manual, single-use
Among tourniquet brands, the SOF® Tactical Tourniquet is one of the top performing medical tourniquets currently available. It is the tourniquet of choice for many of the world's most elite and experienced warriors who have selected it for its outstanding ability to control severe bleeding, high level of reliability and ease of application. While some military units have replaced their issued tourniquets with the SOF®TT, other military units (including special forces) have implemented SOP's stating that the SOF® Tactical Tourniquet is to be used on all lower extremity bleeds. That means the SOF®TT is the tourniquet trusted to control the most severe extremity hemorrhage on the battlefield. The key to successful implementation of a device to be used in a high stress environment is training and ease of use. For law enforcement officers, application of the tourniquet is similar to the use of a hobble. This existing level of familiarity reduces training time and aids in the effectiveness of the device. ADVANTAGES OF THE SOF® TACTICAL TOURNIQUET 100% Effective. Proven to be 100% effective during US Army Institute of Surgical Research testing. Simple application. Unlike other tactical medical tourniquets that require you to learn two methods of application and implement the proper method when under stress, the SOF®TT is applied the same way to an arm or leg. By accounting for the factors of human performance in combat, we have minimized the risk of failure. Applying a tourniquet should not be a multiple choice exam; It should be simple and straight forward. The SOF®TT provides the necessary effectiveness with an unmatched level of simplicity to increase the overall effectiveness of the device. Durability. The SOF®TT is constructed of quality, high-strength materials. The special forces tourniquet handle is machined from a solid piece of aircraft aluminum and maintains its strength in extreme temperatures. The tri-rings are molded Acetyl, a high impact plastic tha
TACTICAL MEDICAL SOLUTIONS, LLC
2
In Commercial Distribution

  • 00818630011538 ()
SOFTT-NH

  • Limb tourniquet, manual, single-use
HALYARD* Filling Extension Set
Avanos Medical, Inc.
13542
In Commercial Distribution

  • 30680651135422 ()
  • 10680651135428 ()


  • General-purpose catheter connector, sterile
Therapeutic medical laser device indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.The noninvasive laser treatments are in the form of non ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA.The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair.The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste.The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
KP4
Not in Commercial Distribution

  • B679KP40 ()
KP4

  • Musculoskeletal/physical therapy laser, professional
Mapping Catheter Extension Cable: deca fixed, duo-deca fixed, duo-deca steerable, 14-pin female
ACCESS POINT TECHNOLOGIES, INC.
901959
In Commercial Distribution

  • 00818083019921 ()

  • Length: 210 Centimeter
901959

  • Electrocardiographic lead/catheter adaptor
Mapping Catheter Extension Cable, deca steerable, 14-pin, male
ACCESS POINT TECHNOLOGIES, INC.
901958
In Commercial Distribution

  • 00818083019914 ()

  • Length: 210 Centimeter
901958

  • Electrocardiographic lead/catheter adaptor
All Smiles Safebond is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials.
Dentscare Ltda
5mL
In Commercial Distribution

  • 07899633830893 ()
4000055911

  • Dentine bonding agent/set
Suppra Universal Bond is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials.
Dentscare Ltda
5mL
In Commercial Distribution

  • 07899633830886 ()
4000055915

  • Dentine bonding agent/set
Suppra O-Cem Plus is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets.
Dentscare Ltda
4g
In Commercial Distribution

  • 07899633828463 ()
4000055571

  • Orthodontic bracket adhesive
Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets.
Dentscare Ltda
4g
In Commercial Distribution

  • 07899633826582 ()
4000055255

  • Orthodontic bracket adhesive
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials.
Dentscare Ltda
5mL
In Commercial Distribution

  • 07899633815944 ()
4000019361

  • Dentine bonding agent/set
CVS Health Gel Toe Protector
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
334560
Not in Commercial Distribution

  • 50050428361523 ()
  • 00050428361528 ()


  • Toe separator
CVS Health Gel Bunion Guard
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
789276
Not in Commercial Distribution

  • 50050428347213 ()
  • 00050428347218 ()


  • Toe separator
CVS Health Gel Toe Wraps
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
548434
Not in Commercial Distribution

  • 50050428341846 ()
  • 00050428341841 ()
  • 60050428341843 ()


  • Toe separator
CVS Health Gel Little Toe Sleeves
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
540650
Not in Commercial Distribution

  • 50050428330390 ()
  • 00050428330395 ()
  • 60050428330397 ()


  • Toe separator
Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose
ETHICON, LLC
4350XL
In Commercial Distribution

  • 20705031147840 ()
  • 10705031147843 ()
4350XL

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
The JAY Union is a versatile, comfortable, skin protection and positioning wheelchair cushion composed of a dynamic fluid and foam layering system.
SUNRISE MEDICAL (US) LLC
Jay Union Cushion
In Commercial Distribution

  • 00016958056402 ()
E2607, E2608

  • Gel-filled chair cushion
Screw Caddy Lid
Paragon 28, Inc.
P27-900-MISL
In Commercial Distribution

  • 00889795133083 ()
P27-900-MISL

  • Device sterilization/disinfection container, reusable
Screw Caddy Base
Paragon 28, Inc.
P27-900-MISC
In Commercial Distribution

  • 00889795133076 ()
P27-900-MISC

  • Device sterilization/disinfection container, reusable
Instrument Tray 2
Paragon 28, Inc.
P27-900-MIT2
In Commercial Distribution

  • 00889795133069 ()
P27-900-MIT2

  • Device sterilization/disinfection container, reusable
Instrument Tray 1
Paragon 28, Inc.
P27-900-MIT1
In Commercial Distribution

  • 00889795133052 ()
P27-900-MIT1

  • Device sterilization/disinfection container, reusable
Case Base
Paragon 28, Inc.
P27-900-MICB
In Commercial Distribution

  • 00889795133045 ()
P27-900-MICB

  • Device sterilization/disinfection container, reusable
Case Lid
Paragon 28, Inc.
P27-900-MICL
In Commercial Distribution

  • 00889795133038 ()
P27-900-MICL

  • Device sterilization/disinfection container, reusable
Curved Elevator
Paragon 28, Inc.
P99-150-2704
In Commercial Distribution

  • 00889795133021 ()
P99-150-2704

  • Periosteal elevator, reusable
Straight Elevator
Paragon 28, Inc.
P99-150-2703
In Commercial Distribution

  • 00889795133014 ()
P99-150-2703

  • Periosteal elevator, reusable
K-wire Tube, Ø4.0 Screw
Paragon 28, Inc.
P27-932-4000
In Commercial Distribution

  • 00889795133007 ()
P27-932-4000

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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