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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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The BeauTis Light S is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis Light S is a medical device that must be operated by medical personnel. The BeauTis Light S is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 20 min operation, 5 min rest for BeauTis Light S
Osstem Implant Co.,Ltd.
BeauTis Light S
In Commercial Distribution

  • 08800000995762 ()


  • Tooth-bleaching acceleration unit
The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth arter applying whitener in order to achieve whitening effect. The BeauTis White Light is a medical device that can be used by male and female adults and can be operated by an individual. The BeauTis White Light is classifiled as Class ll and Type BF applied part. The nornal maximum operation condition is 5 min operation, 5 min rest for BeauTis White Light. The degree of protection against harmful ingress of water is IP21
Osstem Implant Co.,Ltd.
BeauTis White Light
In Commercial Distribution

  • 08800000995755 ()


  • Tooth-bleaching acceleration unit
The intraoral camera with a B applied Part is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures. It can be connected to a USB hub that is connected to be directly connected to a Laptop or Desktop computer USB ports.
Osstem Implant Co.,Ltd.
SNAP Wired
In Commercial Distribution

  • 08800000995656 ()


  • Intraoral camera
This device is an oral camera device that can be magnified in the light of the inside of the mouth, and is used by dentists to photograph the inside of the mouth during oral examination. It consists of a camera head, a battery, a charging cradle, and a receiver module. Investigate the light from the mouth LED to capture the image from the camera module and wirelessly transmit the data via UWB. Additionally, the transmitted image can be viewed using a separate viewer program on the PC ti which the receiver module is connected.
Osstem Implant Co.,Ltd.
SNAP Wireless
In Commercial Distribution

  • 08800000995649 ()


  • Intraoral camera
SUTURE REMOVAL TRAY
E.M. ADAMS, INC.
14-70809JK-1
In Commercial Distribution

  • 50840200325580 ()
  • 10840200325599 ()

  • 6" X 3.75" X .5"


  • Suture removal kit
Laceration Tray
E.M. ADAMS, INC.
114-A3609-1
In Commercial Distribution

  • 50840200325566 ()
  • 10840200325575 ()

  • 8.75" X 7" X 1.25"


  • Suture kit, non-medicated
LACERATION TRAY
E.M. ADAMS, INC.
114-31613-1
In Commercial Distribution

  • 10840200325551 ()
  • 50840200325542 ()

  • 8.75" x 7" x 1.5"


  • Suture kit, non-medicated
SINGLE INSTRUMENT
E.M. ADAMS, INC.
14-3497-1
In Commercial Distribution

  • 50840200325528 ()
  • 10840200325537 ()

  • 5" X 9" POUCH/ALLIGATOR FORCEPS


  • Surgical soft-tissue manipulation forceps, alligator, single-use
SAFETY VEST
E.M. ADAMS, INC.
EP30405L-1
In Commercial Distribution

  • 50840200325443 ()
  • 10840200325452 ()

  • LARGE VEST/1.5" X144" STRAP


  • Limb/torso/head restraint, reusable
SAFETY VEST
E.M. ADAMS, INC.
EP40407XL-1
In Commercial Distribution

  • 50840200325290 ()
  • 10840200325308 ()

  • X LARGE VEST/1.5" X 144" STRAP


  • Limb/torso/head restraint, reusable
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