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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CoolSculpting Securement System Straps Large
Zeltiq Aesthetics, Inc.
CS-SS-LG-02-00
In Commercial Distribution

  • 00816417021640 ()


  • Cryolipolysis body contouring system
CoolSculpting Securement Strap Extra Large
Zeltiq Aesthetics, Inc.
CS-SS-XL-02-00
In Commercial Distribution

  • 00816417021633 ()


  • Cryolipolysis body contouring system
Pre-Treatment Skin Wipe (10 count) package is the lowest level of marketed material.
Zeltiq Aesthetics, Inc.
CS-CD-PSW-10-00
In Commercial Distribution

  • 00816417021626 ()


  • Cryolipolysis body contouring system
Gel Trap V3
Zeltiq Aesthetics, Inc.
CS-GT-V03-10-00
In Commercial Distribution

  • 00816417021534 ()


  • Cryolipolysis body contouring system
CoolSculpting Quad Comfort Strap
Zeltiq Aesthetics, Inc.
CS-SS-QD-02-00
In Commercial Distribution

  • 00816417021527 ()
CS-SS-QD-02-00

  • Cryolipolysis body contouring system
Gel Trap C80
Zeltiq Aesthetics, Inc.
CS-GT-08C-10-00
In Commercial Distribution

  • 00816417021510 ()


  • Cryolipolysis body contouring system
CoolAdvantage Petite Comfort Strap
Zeltiq Aesthetics, Inc.
BRZ-SS1-140-002
In Commercial Distribution

  • 00816417021350 ()
BRZ-SS1-140-002

  • Cryolipolysis body contouring system
Contour, CoolCurve+, CoolAdvantage Petite
Zeltiq Aesthetics, Inc.
BRZ-CN3-140-000
In Commercial Distribution

  • 00816417021152 ()
BRZ-CN3-140-000

  • Cryolipolysis body contouring system
Gasket, 8-Pack, CoolAdvantage Petite       
Zeltiq Aesthetics, Inc.
BRZ-LN1-140-008
In Commercial Distribution

  • 00816417021138 ()
BRZ-LN1-140-008

  • Cryolipolysis body contouring system
Gasket, 8-Pack, CoolAdvantage Plus       
Zeltiq Aesthetics, Inc.
BRZ-LN1-180-008
In Commercial Distribution

  • 00816417021121 ()
BRZ-LN1-180-008

  • Cryolipolysis body contouring system
CoolAdvantage Gasket
Zeltiq Aesthetics, Inc.
BRZ-LN1-160-008
In Commercial Distribution

  • 00816417021114 ()
BRZ-LN1-160-008

  • Cryolipolysis body contouring system
Contour, CoolFit, CoolAdvantage Petite
Zeltiq Aesthetics, Inc.
BRZ-CN2-140-000
In Commercial Distribution

  • 00816417021091 ()
BRZ-CN2-140-000

  • Cryolipolysis body contouring system
Contour, CoolCurve, CoolAdvantage Petite
Zeltiq Aesthetics, Inc.
BRZ-CN1-140-000
In Commercial Distribution

  • 00816417021084 ()
BRZ-CN1-140-000

  • Cryolipolysis body contouring system
CoolAdvantage Petite Gasket - 24 Pack
Zeltiq Aesthetics, Inc.
BRZ-LN2-140-024
In Commercial Distribution

  • 00816417021060 ()
BRZ-LN2-140-024

  • Cryolipolysis body contouring system
Contour, CoolCore Plus, CoolAdvantage Plus
Zeltiq Aesthetics, Inc.
BRZ-CN2-180-000
In Commercial Distribution

  • 00816417020964 ()
BRZ-CN2-180-000

  • Cryolipolysis body contouring system
CoolAdvantage Plus Gel Trap
Zeltiq Aesthetics, Inc.
BRZ-GT1-1X0-008
In Commercial Distribution

  • 00816417020889 ()
BRZ-GT1-1X0-008

  • Cryolipolysis body contouring system
Kit, 16-Pack, Gasket, Contour, CoolAdvantage Plus
Zeltiq Aesthetics, Inc.
BRZ-LN1-180-016
In Commercial Distribution

  • 00816417020803 ()
  • 10816417020800 ()
BRZ-LN1-180-016

  • Cryolipolysis body contouring system
CoolAdvantage Gel Trap - 24 Pack
Zeltiq Aesthetics, Inc.
BRZ-GT1-160-024
In Commercial Distribution

  • 00816417020650 ()
BRZ-GT1-160-024

  • Cryolipolysis body contouring system
Center Securement Plate, CoolSmooth PRO
Zeltiq Aesthetics, Inc.
BRZ-SS4-09X-012
In Commercial Distribution

  • 00816417020537 ()
BRZ-SS4-09X-012

  • Cryolipolysis body contouring system
CoolMini Gel Trap
Zeltiq Aesthetics, Inc.
BRZ-GT1-02X-024
In Commercial Distribution

  • 00816417020100 ()
BRZ-GT1-02X-024

  • Cryolipolysis body contouring system
The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571830 ()
  • 04260484571823 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000022

  • Dermatological extracorporeal shock wave therapy system
The DermaGold100® is intended for treatment of - diabetic footulcers - superficial partial thickness second degree burns in adults (22 years and older). The dermagold100 is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571649 ()
  • 04260484571656 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000014

  • Dermatological extracorporeal shock wave therapy system
The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571274 ()
  • 04260484571267 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000024

  • Dermatological extracorporeal shock wave therapy system
Device for ultrasound therapy
Enraf-Nonius B.V.
1631951
In Commercial Distribution

  • 08720618311108 ()


  • Physical therapy ultrasound system
Device for ultrasound therapy
Enraf-Nonius B.V.
1631940
In Commercial Distribution

  • 08720618311221 ()


  • Physical therapy ultrasound system
Pretreatment Skin Wipes 8 pack
Zeltiq Aesthetics, Inc.
BRZ-PSW-000-008
In Commercial Distribution

  • 10816417020947 ()
  • 00816417020940 ()


  • Cryolipolysis body contouring system
CoolAdvantage Petite Gasket - 24 Pack
Zeltiq Aesthetics, Inc.
BRZ-LN1-140-024
In Commercial Distribution

  • 10816417020916 ()
  • 00816417020919 ()
BRZ-LN1-140-024

  • Cryolipolysis body contouring system
Gasket, 24-Pack, CoolAdvantage
Zeltiq Aesthetics, Inc.
BRZ-LN2-160-024
In Commercial Distribution

  • 10816417020671 ()
BRZ-LN2-160-024

  • Cryolipolysis body contouring system
Assembly Pouched Securement Straps, CoolSmooth
Zeltiq Aesthetics, Inc.
BRZ-SS3-09X-012
In Commercial Distribution

  • 10816417020565 ()
  • 00816417020568 ()
BRZ-SS3-09X-012

  • Cryolipolysis body contouring system
CoolSmooth Securement Strap, Short, Qty
Zeltiq Aesthetics, Inc.
BRZ-SS2-09X-012
In Commercial Distribution

  • 10816417020558 ()
  • 00816417020551 ()
BRZ-SS2-09X-012

  • Cryolipolysis body contouring system
Securement System, Qty 12
Zeltiq Aesthetics, Inc.
BRZ-SS1-09X-012
In Commercial Distribution

  • 10816417020541 ()
  • 00816417020544 ()
BRZ-SS1-09X-012

  • Cryolipolysis body contouring system
CoolSmooth Foam Borders
Zeltiq Aesthetics, Inc.
BRZ-FB1-09X-024
In Commercial Distribution

  • 10816417020152 ()
  • 00816417020155 ()
BRZ-FB1-09X-024

  • Cryolipolysis body contouring system
Pretreatment Skin Wipes
Zeltiq Aesthetics, Inc.
BRZ-PSW-000-024
In Commercial Distribution

  • 10816417020114 ()
  • 00816417020117 ()
BRZ-PSW-000-024

  • Cryolipolysis body contouring system
CoolGel Mini Syringe - 24 Syringes In a Carton
Zeltiq Aesthetics, Inc.
BRZ-GS1-000-024
In Commercial Distribution

  • 10816417020091 ()
  • 00816417020094 ()
BRZ-GS1-000-024

  • Cryolipolysis body contouring system
No Description
Zimmer MedizinSysteme GmbH
5345
In Commercial Distribution

  • 04053815003311 ()
5345

  • Physical therapy ultrasound system
No Description
HILL LABORATORIES CO.
HF54, Horizon
In Commercial Distribution

  • 00860001452532 ()


  • Physical therapy ultrasound system
Welcome to the Omnisound® 3000 Pro, the system that redefines therapeutic ultrasound. While conceiving and designing the Omnisound® 3000 Pro, ACP set out to overcome the limitations of ordinary ultrasound devices. Here are just a few of the functions we developed that make the Omnisound® 3000 Pro truly the future of ultrasound therapy: • Controlled Depth of Penetration - The Omnisound® 3000 Pro enables you to treat soft tissue injuries, superficially with 3 MHz and instantly at the push of a button, treat deeper injuries with 1 MHz - without switching transducers. • Two Transducer Sizes - Our 2cm2 and 5cm2 heads offer optimum flexibility in treatment and are automatically enabled as you change from one to the other. • Combination Therapy - Interconnect port allows combination therapy with the Omnistim® family of electrostimulators. • Excellent BNR and ERA - Our superior BNR and ERA makes for highly uniform and comfortable applications.
ACCELERATED CARE PLUS CORP
1203000E
In Commercial Distribution

  • 10858703006006 ()
  • 00858703006009 ()


  • Physical therapy ultrasound system
The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries and pain relief. sam® X1 is the first wire-free option to deliver continuous wave, high-frequency sustained acoustic medicine (3MHz) into deep tissue resulting in improved circulation and nutrient transfer into the injured soft-tissue for multiple hours each day. This sam® mechanism of action improves and accelerates soft tissue healing for tendinopathies, meniscus injuries, osteoarthritis, joint injuries (knee, shoulder, elbow, wrist) and tissue compromised by repetitive and/or overuse injuries. For pain management secondary to injury, sam® X1 provides localized, non-systemic pain management and is an appropriate treatment alternative for prescribers seeking to avoid the systemic effects of NSAIDs and opiates. sam® X1 is FDA cleared and indicated for prescription home-use, and easily accommodates self-administered treatment by applying the treatment applicator with a hypoallergenic single use pre-filled coupling patch over the soft-tissue injury and activating the battery-operated power controller for autonomous therapeutic delivery.
ZETROZ SYSTEMS, LLC
SA551
In Commercial Distribution

  • 00857599005202 ()
SA551

  • Physical therapy ultrasound system
The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is intended for the treatment of musculoskeletal injuries and pain relief. sam® 2.0 delivers continuous wave, high-frequency sustained acoustic medicine (3MHz) into deep tissue for up to 4 hours, resulting in improved circulation and nutrient transfer into the injured soft-tissue for multiple hours each day. This sam® mechanism of action improves and accelerates soft tissue healing for tendinopathies, meniscus injuries, osteoarthritis, joint injuries (knee, shoulder, elbow, wrist) and tissue compromised by repetitive and/or overuse injuries. For pain management secondary to injury, sam® 2.0 provides localized, non-systemic pain management and is an appropriate treatment alternative for prescribers seeking to avoid the systemic effects of NSAIDs and opiates. sam® 2.0 is FDA cleared and indicated for prescription home-use, and easily accommodates self-administered treatment by applying the treatment applicator with a hypoallergenic single use pre-filled coupling patch over the soft-tissue injury and activating the battery-operated power controller for autonomous therapeutic delivery.
ZETROZ SYSTEMS, LLC
SA271
In Commercial Distribution

  • 00857599005196 ()


  • Physical therapy ultrasound system
wearable therapeutic ultrasound
ZETROZ SYSTEMS, LLC
sam-12
In Commercial Distribution

  • 00857599005073 ()


  • Physical therapy ultrasound system
VIBRALUNG® HHT Hanger
WESTMED, INC.
9641
In Commercial Distribution

  • 10709078002417 ()
  • 00709078002410 ()


  • Electroacoustical airway secretion-clearing system
Demo User Kit with Travel Bag, VIBRALUNG®
WESTMED, INC.
9501D
In Commercial Distribution

  • 00709078002403 ()


  • Electroacoustical airway secretion-clearing system
Demo Treatment Control Unit Assembly, VIBRALUNG® Acoustical
WESTMED, INC.
9500D
In Commercial Distribution

  • 00709078002397 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9643
In Commercial Distribution

  • 10709078001540 ()
  • 00709078001543 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9630
In Commercial Distribution

  • 00709078001536 ()
  • 10709078001533 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9642
In Commercial Distribution

  • 10709078001526 ()
  • 00709078001529 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9646
In Commercial Distribution

  • 00709078001512 ()
  • 10709078001519 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9640
In Commercial Distribution

  • 00709078001376 ()
  • 10709078001373 ()


  • Electroacoustical airway secretion-clearing system
1 each: Standard Y Adapter, Aerosol Y-Adapter, Hand-held Transducer (HHT) assembly with screw-on Cone pre-attached, and disposable ear plugs.
WESTMED, INC.
9600
In Commercial Distribution

  • 00709078001369 ()
  • 10709078001366 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9501
In Commercial Distribution

  • 00709078001345 ()
  • 10709078001342 ()


  • Electroacoustical airway secretion-clearing system
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