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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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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 therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228034094 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
The Radlink GPS Tablet/Monitor Stand functions as a mobile workstation and charger for the Radlink GPS Tablet with a secondary monitor. The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be viewed on the GPS Tablet during surgery, which surgeons can use to reference against the intraoperative images captured during the procedure. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet using the Radlink Wireless C-Arm Kit.
RADLINK, INC.
M STAND
In Commercial Distribution

  • 00864908000148 ()


  • Computed radiography digital imaging scanner
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 3XL
In Commercial Distribution

  • 05391512286521 ()
  • 05391512284343 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 XXL
In Commercial Distribution

  • 05391512286514 ()
  • 05391512284336 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 XL
In Commercial Distribution

  • 05391512286507 ()
  • 05391512284329 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 L
In Commercial Distribution

  • 05391512286491 ()
  • 05391512284312 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 M
In Commercial Distribution

  • 05391512286484 ()
  • 05391512284305 ()
515

  • Abdominal binder, reusable
This abdominal binder belt brace was designed to provide abdominal content containment, particularly during early patient mobilization after abdominal surgery. It provides hernia support, back pain relief, obesity-related discomfort, weak abdominal muscle support and is very effective to help with post-pregnancy abdominal support. This binder is available in a wide range of sizes up to 55-inch circumference and is 10.2 inches in height. It is made with two wide panels providing an innovative locking system based on twin crisscrossing straps that offer an easy fit for all different shapes and sizes. Easy to put and adjustable for a comfortable fit. Made with the patient in mind, with super soft natural materials, 85% Cotton,and 15% Elastane. Made in Italy. Benefits: 24H COMFORT, SUPER SLIM, BREATHABLE, ULTRA LIGHT, EASY TO USE, WASHABLE, WATER WICKING FIBERS, TWO WIDE PANEL STRAPS, ADJUSTABLE COMPRESSION. INDICATIONS Umbilical Hernia Post Pregnancy Abdomen Support Hernia Support Back Support Abdomen Injury Post Surgery Support General Abdomen Containment
INDACO SRL
515 S
In Commercial Distribution

  • 05391512286477 ()
  • 05391512284299 ()
515

  • Abdominal binder, reusable
Designed for both transitional and long-term denture stabilization, the ERA Micro Dental Implant features the capability to correct implant misangulation. Four unique angle options offer flexibility to achieve the desired path of insertion for denture stabilization, even when implants are placed in narrow, resorbed ridges. The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments. Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. Intended for For surgical implantation in the maxillary or mandibular arch to support dental restorations such as artificial teeth, in order to restore the patient’s chewing function. Intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems.
STERNGOLD DENTAL LLC
901533
Not in Commercial Distribution

  • 00841549108433 ()


  • Dental implant suprastructure, permanent, preformed
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