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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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KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
IBA Dosimetry GmbH
2
In Commercial Distribution

  • EIBA120131261 ()
  • EIBA120131260 ()
120-131ZKCANO

  • Diagnostic x-ray system quality assurance device
MANI CARBIDE BURS
MANI, INC.
2
In Commercial Distribution

  • 74546951534379 ()
  • 04546951534370 ()


  • Carbide dental bur, reusable
31-115 TMT Tourniquet 1.00EA GLOVES-2.00.101 Synmax, Blue, Industrial Grade, Powered Free, Latex Free 1.00 PR 30-212 MARCH Celox Rapid B-CON 3"x2' OTC 1.00EA 11-100-QR-EN POSTIONAL AIRWAY - ENGLISH 2.00 1.00EA L-SDR-VSIP-OTC-REFILSDR Vehicle Kit - OTC-Refill Insert 1.00EA 20-001-KOI Sentinel Chest Seal 2.00 1.00EA FCP-01 ETD 1.00EA BPS-47 Blizzard IFAK 1.00EA 95-000-QR-EN MARCH Cover QR Card - English 1.00EA 31-115-QR-EN TMT - ENGLISH 1.00EA 30-212-QR-EN CELOX RAPID B-CON - ENGLISH 1.00EA 20-001-QR-EN SENTINEL CHEST SEAL - ENGLISH 1.00EA 32-150-QR-EN COMPRESSION DRESSING - ENGLISH 1.00EA 04-101-QR-EN EMERGENCY BLANKET - ENGLISH 1.00EA P81-111 Snap Ring, 1/2" ID, Acetal (.55/13.5mm ID) 1.00EA L01-00 33x1 blank polypropylene TT label 1.00EA P81-250-07 Inner Pouch, PA Kit 7x1 1.00EA P59-100 Inner Pouch, Hypothermia Kit 1.00EA
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689SDRVSIPOTCREFILL020 ()
SDR-VSIP-OTC

  • First aid kit, non-medicated, single-use
Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689BH01020 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
SONIO Pro is intended to be used by healthcare professionals HCP during OB/GYN exams. It is a software connected to the Ultrasound equipment through a Sonio Edge Software installed in the HCP network that can send and upload media sent by the Ultrasound equipments in DICOM format, act as a Worklist for those Ultrasound equipments as well as interact with the IT solutions of the HCP through HL7 protocol (interoperability with the EMR, Billing System, ...) .
SONIO
2
In Commercial Distribution

  • 03770024341010 ()


  • Medical image management system
No Description
LUCERNO DYNAMICS, LLC
2
In Commercial Distribution

  • 00850014578268 ()
  • 00850014578091 ()
401874-200

  • Scintillation-counter radiation survey meter
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following: - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station, intended to recharge the wireless handpiece and - The External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
2
In Commercial Distribution

  • 05430003362037 ()


  • Electrosurgical handpiece, reusable
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following: - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station, intended to recharge the wireless handpiece and - The External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
2
In Commercial Distribution

  • 05430003362006 ()


  • Electrosurgical handpiece, reusable
DIEGO is a robotic arm-shoulder therapy system for the rehabilitation of patients with limited arm function.
tyromotion GmbH
2
In Commercial Distribution

  • 09120077180021 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
Bone Curette, Octagonal Grip, Double Ended
A. TITAN INSTRUMENTS, INC.
2
In Commercial Distribution

  • 00841685103200 ()


  • Bone curette, reusable
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