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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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Unite Medical® - 00850012035442

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, XLarge)
In Commercial Distribution

  • 00850012035442 ()
KO4552R-XL

  • Knee support orthosis

Unite Medical® - 00850012035428

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Large)
In Commercial Distribution

  • 00850012035428 ()
KO4552R-L

  • Knee support orthosis

Unite Medical® - 00850012035411

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Medium)
In Commercial Distribution

  • 00850012035411 ()
KO4552R-M

  • Knee support orthosis

Unite Medical® - 00850012035404

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, XLarge)
In Commercial Distribution

  • 00850012035404 ()
KO4552L-XL

  • Knee support orthosis

Unite Medical® - 00850012035398

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, Large)
In Commercial Distribution

  • 00850012035398 ()
KO4552L-L

  • Knee support orthosis

Unite Medical® - 00850012035381

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left, Medium)
In Commercial Distribution

  • 00850012035381 ()
KO4552L-M

  • Knee support orthosis

Unite Medical® - 00850012035374

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Right, Small)
In Commercial Distribution

  • 00850012035374 ()
KO4552R-S

  • Knee support orthosis

Unite Medical® - 00850012035367

The Unite Medical® Double Upright Knee Orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A double upright design in conjunction with flex-hinge to unload the medial and lateral compartments of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Double Upright Knee Orthosis (Left,Small)
In Commercial Distribution

  • 00850012035367 ()
KO4552L-S

  • Knee support orthosis

Unite Medical® - 00850012035251

The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Single Upright Knee Orthosis (Right, Universal)
In Commercial Distribution

  • 00850012035251 ()
KO4351R

  • Knee support orthosis

Unite Medical® - 00850012035244

The Unite Medical® single upright knee orthosis helps to relieve pain associated with ligament injuries of the ACL, PCL, MCL, LCL, and mild to moderate arthritis. A single lateral upright design in conjunction with flex-hinge to unload the medial compartment of the knee, helps to promote normal joint movement and reduce pain.
Unite Medical, LLC
Single Upright Knee Orthosis (Left, Universal)
In Commercial Distribution

  • 00850012035244 ()
KO4351L

  • Knee support orthosis

Unite Medical® - 00850012035138

The Unite Medical® Deluxe Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Deluxe Universal ROM Knee Brace
In Commercial Distribution

  • 00850012035138 ()
KO3233-1

  • Knee support orthosis

Unite Medical® - 00850012035121

The Unite Medical® Universal ROM Knee Brace is indicated for mild to moderate ligament joint pain, sprains, and strains of the knee ligaments. This lightweight brace design connects the needs of the serious athlete with the added benefit of Range of Motion (ROM). Removable hinges allow for easy adjustment.
Unite Medical, LLC
Universal ROM Knee Brace
In Commercial Distribution

  • 00850012035121 ()
KO3233

  • Knee support orthosis

Verifine - 00850011833834

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7103106-100
In Commercial Distribution

  • 10850011833831 ()
  • 00850011833834 ()
  • 80850011833830 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833827

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033106-100
In Commercial Distribution

  • 10850011833824 ()
  • 00850011833827 ()
  • 80850011833823 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833797

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8103108-100
In Commercial Distribution

  • 10850011833794 ()
  • 00850011833797 ()
  • 80850011833793 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833780

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8102912-100
In Commercial Distribution

  • 10850011833787 ()
  • 00850011833780 ()
  • 80850011833786 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833773

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8053108-100
In Commercial Distribution

  • 10850011833770 ()
  • 00850011833773 ()
  • 80850011833779 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833766

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8052912-100
In Commercial Distribution

  • 10850011833763 ()
  • 00850011833766 ()
  • 80850011833762 ()


  • Insulin syringe/needle, basic

Verifine - 00850011833759

The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033108-100
In Commercial Distribution

  • 10850011833756 ()
  • 00850011833759 ()
  • 80850011833755 ()


  • Insulin syringe/needle, basic

Home Base Station (Bluetooth) - 00850015699153

The Canary Home Base Station (Bluetooth) subsystem is a unit with embedded firmware that facilitate communication with CTE and CSE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-15
In Commercial Distribution

  • 00850015699153 ()


  • Medical networking interface unit

Hermes PEEK Curve Cage - 00850015638893

Hermes TyPEEK Curve Cage 13mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2813023-S
In Commercial Distribution

  • 00850015638893 ()
HRM-T2813023-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638886

Hermes TyPEEK Curve Cage 12mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2812023-S
In Commercial Distribution

  • 00850015638886 ()
HRM-T2812023-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638879

Hermes TyPEEK Curve Cage 11mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2811023-S
In Commercial Distribution

  • 00850015638879 ()
HRM-T2811023-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638862

Hermes TyPEEK Curve Cage 10mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2810023-S
In Commercial Distribution

  • 00850015638862 ()
HRM-T2810023-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638848

Hermes TyPEEK Curve Cage 8mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T288023-S
In Commercial Distribution

  • 00850015638848 ()
HRM-T288023-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638817

Hermes TyPEEK Straight Cage 11mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2811012-S
In Commercial Distribution

  • 00850015638817 ()
HRM-P2811012-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638800

Hermes TyPEEK Straight Cage 10mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2810012-S
In Commercial Distribution

  • 00850015638800 ()
HRM-P2810012-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638787

Hermes TyPEEK Straight Cage 8mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P288012-S
In Commercial Distribution

  • 00850015638787 ()
HRM-P288012-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638770

Hermes TyPEEK Straight Cage 13mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2413010-S
In Commercial Distribution

  • 00850015638770 ()
HRM-P2413010-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638763

Hermes TyPEEK Straight Cage 12mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2412010-S
In Commercial Distribution

  • 00850015638763 ()
HRM-P2412010-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638756

Hermes TyPEEK Straight Cage 11mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2411010-S
In Commercial Distribution

  • 00850015638756 ()
HRM-P2411010-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638749

Hermes TyPEEK Straight Cage 10mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2410010-S
In Commercial Distribution

  • 00850015638749 ()
HRM-P2410010-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638732

Hermes TyPEEK Straight Cage 9mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P249010-S
In Commercial Distribution

  • 00850015638732 ()
HRM-P249010-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638725

Hermes TyPEEK Straight Cage 8mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P248010-S
In Commercial Distribution

  • 00850015638725 ()
HRM-P248010-S

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638718

Hermes PEEK Curve Cage 13mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2813023
In Commercial Distribution

  • 00850015638718 ()
HRM-T2813023

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638701

Hermes PEEK Curve Cage 12mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2812023
In Commercial Distribution

  • 00850015638701 ()
HRM-T2812023

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638695

Hermes PEEK Curve Cage 11mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2811023
In Commercial Distribution

  • 00850015638695 ()
HRM-T2811023

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638688

Hermes PEEK Curve Cage 10mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T2810023
In Commercial Distribution

  • 00850015638688 ()
HRM-T2810023

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638671

Hermes PEEK Curve Cage 9mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T289023
In Commercial Distribution

  • 00850015638671 ()
HRM-T289023

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Curve Cage - 00850015638664

Hermes PEEK Curve Cage 8mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-T288023
In Commercial Distribution

  • 00850015638664 ()
HRM-T288023

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638657

Hermes PEEK Straight Cage 13mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2813012
In Commercial Distribution

  • 00850015638657 ()
HRM-P2813012

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638640

Hermes PEEK Straight Cage 12mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2812012
In Commercial Distribution

  • 00850015638640 ()
HRM-P2812012

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638633

Hermes PEEK Straight Cage 11mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2811012
In Commercial Distribution

  • 00850015638633 ()
HRM-P2811012

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638626

Hermes PEEK Straight Cage 10mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P2810012
In Commercial Distribution

  • 00850015638626 ()
HRM-P2810012

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638619

Hermes PEEK Straight Cage 9mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P289012
In Commercial Distribution

  • 00850015638619 ()
HRM-P289012

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638602

Hermes PEEK Straight Cage 8mmx28mmx12mm, 0°
Tyber Medical LLC
HRM-P288012
In Commercial Distribution

  • 00850015638602 ()
HRM-P288012

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638596

Hermes PEEK Straight Cage 13mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2413010
In Commercial Distribution

  • 00850015638596 ()
HRM-P2413010

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638589

Hermes PEEK Straight Cage 12mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2412010
In Commercial Distribution

  • 00850015638589 ()
HRM-P2412010

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638572

Hermes PEEK Straight Cage 11mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2411010
In Commercial Distribution

  • 00850015638572 ()
HRM-P2411010

  • Metal-polymer composite spinal interbody fusion cage

Hermes PEEK Straight Cage - 00850015638565

Hermes PEEK Straight Cage 10mmx24mmx10mm, 0°
Tyber Medical LLC
HRM-P2410010
In Commercial Distribution

  • 00850015638565 ()
HRM-P2410010

  • Metal-polymer composite spinal interbody fusion cage
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