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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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Lasik 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.
658E
In Commercial Distribution

  • 10810003223675 ()
658E

  • Ophthalmic surgical procedure kit, non-medicated, single-use
Lasik 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.
467L
In Commercial Distribution

  • 10810003223668 ()
467L

  • Ophthalmic surgical procedure kit, non-medicated, single-use
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 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
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 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-PbS-XXL
In Commercial Distribution

  • 00850035588796 ()


  • 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-PbS-MD
In Commercial Distribution

  • 00850035588765 ()


  • 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-PbS-SM
In Commercial Distribution

  • 00850035588758 ()


  • 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-PbS-XL
In Commercial Distribution

  • 00850035588789 ()


  • 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-PbS-LG
In Commercial Distribution

  • 00850035588772 ()


  • 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-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
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-MD
In Commercial Distribution

  • 00850035588444 ()


  • 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-SM
In Commercial Distribution

  • 00850035588437 ()


  • 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-3XL
In Commercial Distribution

  • 00850035588222 ()


  • Radiation shielding apron
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: burgundy.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300111 ()
  • E307220300110 ()
22030011

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: blue lagoon.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300101 ()
  • E307220300100 ()
22030010

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: blue.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300090 ()
22030009

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: orange.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300080 ()
22030008

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: grey.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300071 ()
  • E307220300070 ()
22030007

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: lime.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300060 ()
22030006

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: pink.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300050 ()
22030005

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: lilac.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300041 ()
  • E307220300040 ()
22030004

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: yellow.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300030 ()
22030003

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: green.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300021 ()
  • E307220300020 ()
22030002

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: light blue.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300011 ()
  • E307220300010 ()
22030001

  • Patient examination/treatment drape, single-use
Disposable patient protection aprons consisting of a highly absorbent multiple-ply paper embossed with a waterproof polyethylene layer, without the use of glues. Soft and comfortable, compared to traditional towels, they offer larger dimensions and functional contouring on the neck and shoulders for complete patient protection and practical adhesives for fixing. Pack of 150 aprons. Colour: white.
EURONDA SPA
Monoart Bib Up!
In Commercial Distribution

  • E307220300000 ()
  • E307220300001 ()
22030000

  • Patient examination/treatment drape, 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
UV - Tanning lamp, Accession # 0920281-000 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: NARVA G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Strahler OH M Blue Q 500 S
Not in Commercial Distribution

  • 04054657500402 ()
  • 14054657500409 ()
  • 54054657600404 ()
8003 7198

  • Ultraviolet tanning device
UV - Tanning lamp, Accession # 0920280-000 <CR> <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: NARVA G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Strahler OH M Blue Q 501 EC
Not in Commercial Distribution

  • 04054657500396 ()
  • 14054657500393 ()
  • 54054657600398 ()
8004 0601

  • Ultraviolet tanning device
UV - Tanning lamp, Accession # 0920279-000 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, info@original-hanau.com, http://www.original-hanau.com <CR> Manufacturer: NARVA G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Strahler OH M Blue Q 500 EC
Not in Commercial Distribution

  • 04054657500389 ()
  • 14054657500386 ()
  • 54054657600381 ()
8003 7208

  • Ultraviolet tanning device
Cable link, FR3 to CPR meter
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Cable Link to Q CPR Meter
Not in Commercial Distribution

  • 00884838049949 ()
989803149951

  • Non-rechargeable professional semi-automated external defibrillator
Cardiart TS6000 Premium Cardiology Stethoscope Black aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
IMEDIPLUS INC.
TS6000 Premium Black
In Commercial Distribution

  • 04719874400200 ()


  • Mechanical external stethoscope
IMEDIPLUS TS-3000D Dual Head Stethoscope Black aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
IMEDIPLUS INC.
TS-3000D Black
In Commercial Distribution

  • 04719874400187 ()


  • Mechanical external stethoscope
IMEDIPLUS TS-3000D Dual Head Stethoscope Blue aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
IMEDIPLUS INC.
TS-3000D Blue
In Commercial Distribution

  • 04719874400170 ()


  • Mechanical external stethoscope
IMEDIPLUS TS-3000S Black Single Head Stethoscope aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
IMEDIPLUS INC.
TS-3000S Black
In Commercial Distribution

  • 04719874400156 ()


  • Mechanical external stethoscope
IMEDIPLUS TS-3000S Blue Single Head Stethoscope aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
IMEDIPLUS INC.
TS-3000S Blue
In Commercial Distribution

  • 04719874400149 ()


  • Mechanical external stethoscope
Cardiart Dual Head Stethoscope TS3000DL (Double-lumen) aids to the auscultation needs and is designed to suit the individual requirement for each physician. The chestpiece is easy to grip with finger contoured holder and the ear tips with the soft texture are comfortable to wear, moreover, it could provide a good sealant for reducing environmental noise and offer a good sound quality for users.
IMEDIPLUS INC.
TS3000DL
In Commercial Distribution

  • 04719874400125 ()


  • Mechanical external stethoscope
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