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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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SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
100X25X8 MM, 20 CC
In Commercial Distribution

  • 00816986020501 ()
SGFS-020

  • Synthetic bone graft
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
50X25X8 MM, 10 CC
In Commercial Distribution

  • 00816986020495 ()
SGFS-010

  • Synthetic bone graft
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
25X25X8 MM, 5 CC
In Commercial Distribution

  • 00816986020488 ()
SGFS-005

  • Synthetic bone graft
The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MZ-07
In Commercial Distribution

  • 00731093153136 ()


  • Hair growth laser device
The Invisalign System with Mandibular advancement - enhanced precision wings (EPW) is used to treat patients with Class I and Class II malocclusion, severe open bit, severe overjet, deep bit, skeletally narrow jaw, and dental prostheses/implants, and/or those who require surgical correction. The EPW are modified precision wings with longer and curved wings, with an added rib on buccal side, which are designed to optimize mandibular advancement.
Align Technology, Inc.
222715
In Commercial Distribution

  • 00816063022145 ()


  • Orthodontic progressive aligner
ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17" swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27" x 11"), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Advanced Connectivity includes WLAN, LAN, USB, DICOM, and Enterprise; Patient Demographic Query (PDQ); AM12 Wired Acquisition Module; I
WELCH ALLYN, INC.
901133
In Commercial Distribution

  • 00732094301663 ()
ELI380-DCP22

  • Electrocardiograph, professional, multichannel
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen.
FOTONA d.o.o.
M321-B
In Commercial Distribution

  • 03830054230408 ()


  • Dental solid-state laser system
  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen.
FOTONA d.o.o.
M321-A
In Commercial Distribution

  • 03830054230392 ()


  • Dental solid-state laser system
  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1 WAY / 2 WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the I or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1IWAY I 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.
LABORATORIOS GRIFOLS SA
1 way
Not in Commercial Distribution

  • 28426314601164 ()
  • 08426314601160 ()


  • Fluid transfer set, general-purpose
Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 110V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 24 telemetry channels (dual display required); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG i
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094294798 ()
SCSYS-IAE-LHFAX

  • Centralized patient monitor
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