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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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The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.
Diversified Healthcare Development, LLC
KB01
In Commercial Distribution

  • 00858458007009 ()


  • Balance/cognitive function analysis system
The extended life laparoscopic tip is intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. The CUSA Excel System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: • Neurosurgery • Gastrointestinal and affiliated organ surgery • Urological surgery • Plastic and reconstructive surgery • General surgery • Orthopedic surgery • Gynecological surgery • Thoracic surgery • Laparoscopic surgery • Thoracoscopic surgery
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C4604ELTUS
In Commercial Distribution

  • 30381780248242 ()
  • 10381780248248 ()
  • M269C4604ELTUS1 ()

  • Length 30.14 cm; Diameter 1.98mm


  • Soft-tissue ultrasonic surgical system handpiece tip, reusable
NovoSorb® BTM is a biodegradable polyurethane porous matrix adhered to a transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the matrix. NovoSorb® BTM is supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® BTM is a fenestrated single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope.
POLYNOVO BIOMATERIALS PTY LIMITED
BTM-1020
In Commercial Distribution

  • 09349155000130 ()
  • 09349155000147 ()
  • 09349155000154 ()

  • Length: 10 Centimeter
  • Width: 20 Centimeter


  • Synthetic wound matrix dressing
ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound." Dressing is perforated to allow passage of thick exudate.
MILLIKEN HEALTHCARE PDTS, LLC
Perforated 6"x6"
In Commercial Distribution

  • 00015961681519 ()
  • 10015961681516 ()
  • 20015961681513 ()
  • 30015961681510 ()
3000119463

  • Wound-nonadherent dressing, permeable, antimicrobial
ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound." Dressing is perforated to allow passage of thick exudate.
MILLIKEN HEALTHCARE PDTS, LLC
Perforated 4"x48"
In Commercial Distribution

  • 10015961681509 ()
  • 00015961681502 ()
  • 20015961681506 ()
3000119464

  • Wound-nonadherent dressing, permeable, antimicrobial
ASSIST Silver is a sterile, single use antimicrobial wound contact layer. The dressing is a multicomponent substrate with a low adherent wound contact surface laminated to a polyester/nylon fabric coated with an ion-exchange silver. ASSIST Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. ASSIST Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy. The navy print is a circle logo with"Milliken" above and "ASSIST Silver" printed inside. The dressing is also printed with navy "this side away from wound." Dressing is perforated to allow passage of thick exudate.
MILLIKEN HEALTHCARE PDTS, LLC
Perforated 8"x20"
In Commercial Distribution

  • 00015961681496 ()
  • 10015961681493 ()
  • 20015961681490 ()
3000119465

  • Wound-nonadherent dressing, permeable, antimicrobial
150 QUIET! PLEASE 10 PR 150 QP 10 PR E/P IN SHELF TRAY
APOTHECARY PRODUCTS, LLC
F408-150/F408-150ST/F408-150WM1
In Commercial Distribution

  • 40023185680025 ()
  • 00023185081503 ()
  • 20023185081507 ()
  • 10023185081500 ()
  • 20023185025488 ()
  • 10023185604259 ()
  • 20025715034786 ()
  • 10025715039296 ()


  • Earplugs, single-use
The NSS Neurostim ((510K-140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
NeuroStim
In Commercial Distribution

  • B960NSS201 ()
  • B960NSS2011 ()
  • B960NSS2012 ()
  • B327NSS201 ()
  • B960NSS2013 ()
01-1021

  • Acupuncture electrical stimulation system
Acellular fish skin for topical and surgical wounds. "Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
KERECIS hf.
3x3.5 Particularized Wound
Not in Commercial Distribution

  • 05694310960939 ()

  • Width: 3 Centimeter
  • Length: 3.5 Centimeter
50200P01D0D

  • Animal-derived wound matrix dressing
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOINSIGHTS110 ()


  • Home pharmaceutical management support software
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