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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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Ophthalmic pack. PRO-PAKS Personalized Eye Tray Systems offer the best option for Surgical Packs and a Systematized approach combined with the Personal Touch. PRO-PAKS personalized procedure trays offers a fully custom pack, from EXACT components to EXACT quantities and the ability to adapt the sequence of which the individual items are placed in the pack.
MICROSPECIALITIES, INC.
21443C
In Commercial Distribution

  • 10810003223903 ()
21443C

  • Ophthalmic surgical procedure kit, non-medicated, single-use
Ophthalmic pack. PRO-PAKS Personalized Eye Tray Systems offer the best option for Surgical Packs and a Systematized approach combined with the Personal Touch. PRO-PAKS personalized procedure trays offers a fully custom pack, from EXACT components to EXACT quantities and the ability to adapt the sequence of which the individual items are placed in the pack.
MICROSPECIALITIES, INC.
21442E
In Commercial Distribution

  • 10810003223897 ()
21442E

  • Ophthalmic surgical procedure kit, non-medicated, single-use
This product can be used to make a very aesthetic retainer called Q C M Retainer W The best feature of this product is that the resin part and the wire part are connected by screws so if the resin part gets dirty or damaged the resin part can be replaced
CHIKAMI MILTEC INC.
RWL-W50
In Commercial Distribution

  • 04570077940326 ()


  • Orthodontic retainer
This product can be used to make a very aesthetic retainer called Q C M Retainer W The best feature of this product is that the resin part and the wire part are connected by screws so if the resin part gets dirty or damaged, the resin part can be replaced.
CHIKAMI MILTEC INC.
RWS-W50
In Commercial Distribution

  • 04570077940302 ()


  • Orthodontic retainer
The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam.
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
3.0
In Commercial Distribution

  • 00860001130508 ()


  • Ophthalmology PACS software
The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS 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 consists of a computer system that uses one ultra-wide monitor.
RADLINK, INC.
GPS Trauma
In Commercial Distribution

  • 00864908000162 ()


  • Computed radiography digital imaging scanner
Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-handed and four-handed treatment sequences as well as both left-handed and right-handed use. The unit is equipped with a digital control system with graphical user interface (GUI) to offer ease of use.The instrument console includes six instrument locations, with easy instrument interchange.
Planmeca Oy
Classic
Not in Commercial Distribution

  • 06430035420100 ()
10032746, 10032747

  • Dental delivery system
The Barrier Flex provides excellent weight distribution and comfort. Two full adjustable Velcro straps cross in the back and attach in the front providing a comfortable fit while keeping the apron securely on the shoulders. Adjustable elastic inserts in the rear flaps offer greater comfort, adjustment and support. Comfortable fit during long procedures. Shoulder pads provide additional comfort.
Barrier Technologies, LLC
BF-PbF-XXL
In Commercial Distribution

  • 00850035588475 ()


  • Radiation shielding apron
The Barrier Flex provides excellent weight distribution and comfort. Two full adjustable Velcro straps cross in the back and attach in the front providing a comfortable fit while keeping the apron securely on the shoulders. Adjustable elastic inserts in the rear flaps offer greater comfort, adjustment and support. Comfortable fit during long procedures. Shoulder pads provide additional comfort.
Barrier Technologies, LLC
BF-PbF-XL
In Commercial Distribution

  • 00850035588468 ()


  • Radiation shielding apron
The Barrier Flex provides excellent weight distribution and comfort. Two full adjustable Velcro straps cross in the back and attach in the front providing a comfortable fit while keeping the apron securely on the shoulders. Adjustable elastic inserts in the rear flaps offer greater comfort, adjustment and support. Comfortable fit during long procedures. Shoulder pads provide additional comfort.
Barrier Technologies, LLC
BF-PbF-LG
In Commercial Distribution

  • 00850035588451 ()


  • Radiation shielding apron
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