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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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Koya Medical - 00850012532026

Arm Garmet, Dayspring, Long
Koya Medical, Inc.
F-0010-03
In Commercial Distribution

  • 00850012532026 ()
F-0010-03

  • Wearable sequential venous compression system

Koya Medical - 00850012532019

Arm Garmet, Dayspring, Medium
Koya Medical, Inc.
F-0010-02
In Commercial Distribution

  • 00850012532019 ()
F-0010-02

  • Wearable sequential venous compression system

Koya Medical - 00850012532002

Arm Garmet, Dayspring, Short
Koya Medical, Inc.
F-0010-01
In Commercial Distribution

  • 00850012532002 ()
F-0010-01

  • Wearable sequential venous compression system

Claritag Advanced - 00850001389242

Cryogenic Skin Tag Removal
Dgi Group LLC
AZ-6055
In Commercial Distribution

  • 00850001389242 ()


  • Wart-removal cryogenic kit

Claritag Advanced - 00850001389167

Cryogenic Skin Tag Remover
Dgi Group LLC
AZ-6055
In Commercial Distribution

  • 00850001389167 ()


  • Wart-removal cryogenic kit

Freeze Away 8ct - 10888853002962

Cryogenic Wart remover
SCHOLL'S WELLNESS COMPANY LLC
90000335
In Commercial Distribution

  • 10888853002962 ()
  • 00888853002965 ()


  • Wart-removal cryogenic kit

Freeze Away Dual Action 8ct - 10888853002955

Combination Cryogenic and Liquid Wart Remover
SCHOLL'S WELLNESS COMPANY LLC
90000336
In Commercial Distribution

  • 00888853002958 ()
  • 10888853002955 ()


  • Wart-removal cryogenic kit

Freeze Away Dual Action Wart Remover - 10888853001330

Cryogenic wart remover kit
SCHOLL'S WELLNESS COMPANY LLC
90000336
In Commercial Distribution

  • 00888853001333 ()
  • 10888853001330 ()


  • Wart-removal cryogenic kit

Freeze Away Wart Remover - 10888853000128

Cryogenic wart remover
SCHOLL'S WELLNESS COMPANY LLC
90000072
In Commercial Distribution

  • 00888853000107 ()
  • 10888853000128 ()


  • Wart-removal cryogenic kit

Chembio HIV Reactive/Nonreactive Controls - 00607158000076

The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control). One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies. One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9549-0
In Commercial Distribution

  • 00607158000076 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
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