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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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Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display.
Sugentech Inc._Osong Branch
SU-DR02-CG
In Commercial Distribution

  • 08809408860191 ()
HCGR001E

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
This product irradiates the skin with red light in the wavelength range of 630 to 690 nm and infrared light in the wavelength range of 820 to 880 nm. Treatment of wrinkles all over the face. This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
STG24 Co.,Ltd.
MQ-M21M4
In Commercial Distribution

  • 08809362081458 ()
  • 28809362081452 ()
  • 18809362081455 ()


  • Cosmetic red-light phototherapy system, home-use
11mm/90°/2300mm
FINEMEDIX CO.,LTD.
FM-CLD11-090(2300)
In Commercial Distribution

  • 18809327353092 ()
  • 08809327353095 ()


  • Gastrointestinal endoscopic clip, short-term
11mm/90°/1650mm
FINEMEDIX CO.,LTD.
FM-CLD11-090(1650)
In Commercial Distribution

  • 18809327353085 ()
  • 08809327353088 ()


  • Gastrointestinal endoscopic clip, short-term
Digital Wide-Tip Pregnancy Test
H. E. BUTT GROCERY COMPANY
HEB DPS DIG Wide-Tip Blue
In Commercial Distribution

  • 10197870071494 ()
  • 00197870071497 ()
  • 00633472000072 ()
N/A

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
A convenience kit consisting of 1 Digital Wide-Tip Test and 1 Early Result Test
H. E. BUTT GROCERY COMPANY
HEB DIG Wide-Tip & VIS Pink
In Commercial Distribution

  • 10197870071487 ()
  • 00197870071480 ()
N/A

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
STARTER KIT, GLUCOSE, EVENCARE G2 BT
MEDLINE INDUSTRIES, INC.
MPH1545BT
In Commercial Distribution

  • 00197344007595 ()
MPH1545BT

  • Glucose monitoring system IVD, home-use
Albertsons DPS One Step +/-
BETTER LIVING BRANDS LLC
One Step Pregnancy Test
In Commercial Distribution

  • 10321130352942 ()
  • 00321130352945 ()
  • 00633472000133 ()
N/A

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Albertsons DPS DIG Wide-Tip Blue
BETTER LIVING BRANDS LLC
Digital Wide-Tip Pregnancy Test
In Commercial Distribution

  • 10321130351112 ()
  • 00321130351115 ()
  • 00633472000072 ()
N/A

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Early Result Pregnancy Test - 3 Tests with Insert
WALGREEN CO.
MidStream 6
In Commercial Distribution

  • 00311917215747 ()
  • 00748349000540 ()
  • 10311917215744 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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