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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Battery Vacuum Pump
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Battery Vacuum Pump
In Commercial Distribution

  • 00852598007059 ()


  • Penile vacuum device
Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. Vashe® Wound Solution OTC is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
URGO MEDICAL NORTH AMERICA, LLC
00405
In Commercial Distribution

  • 10190769004054 ()
  • 00190769004057 ()

  • Total Volume: 250 Milliliter
00405

  • Antimicrobial wound irrigation solution
The Stork® OTC packages include: Instructions for Use (IFU), one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female’s most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.
STORK IB2C, INC., THE
USOTC
In Commercial Distribution

  • 00810396020007 ()


  • Conceptive cervical cap, single-use
No Description
Orasure Technologies, Inc.
1001-0340
In Commercial Distribution

  • 10608337103400 ()
  • 00608337103403 ()
  • 00608337000948 ()
  • 20608337103407 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
No Description
Orasure Technologies, Inc.
1001-0528
In Commercial Distribution

  • 10608337001331 ()
  • 00608337001334 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
No Description
Orasure Technologies, Inc.
1001-0374
In Commercial Distribution

  • 10608337000969 ()
  • 00608337000962 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
No Description
Orasure Technologies, Inc.
3001-1197
In Commercial Distribution

  • 20608337000010 ()
  • 00608337000016 ()
  • 10608337000013 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Dr. Scholl's Freeze Away Wart Remover ( Yellow Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: Pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators and information booklet.
BAYER HEALTHCARE LLC
1612171
Not in Commercial Distribution

  • 10311017405342 ()
  • 00311017405345 ()


  • Wart-removal cryogenic kit
Dr. Scholl's Freeze Away Wart Remover ( blue Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators and information booklet.
BAYER HEALTHCARE LLC
1612171
Not in Commercial Distribution

  • 10311017405328 ()
  • 00311017405321 ()


  • Wart-removal cryogenic kit
Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.
BAYER HEALTHCARE LLC
1612171
Not in Commercial Distribution

  • 10311017405304 ()
  • 00311017405307 ()


  • Wart-removal cryogenic kit
Piezo-electric stimulator for temporary reduction of itching and swelling resulting from mosquito bites
WALGREEN CO.
Bite Relief
In Commercial Distribution

  • 00182097000412 ()
  • 00311917206721 ()
  • 10311917206728 ()
  • 20311917206725 ()


  • Insect bite/sting electrical stimulator
One Step Freeze Wart Remover
WALGREEN CO.
781950
In Commercial Distribution

  • 10311917201419 ()
  • 00311917201412 ()

  • Height: 155 Millimeter
781950

  • Wart-removal cryogenic kit
Extreme Blister Cushions, one size, 1.65 IN x 2.67 IN (42 mm x 68 mm)
WALGREEN CO.
400569
In Commercial Distribution

  • 10311917195657 ()
  • 00311917195650 ()
  • 60311917195652 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-sterile
Wart Freezer 1-Step Wart Remover
WALGREEN CO.
336146
Not in Commercial Distribution

  • 10311917164295 ()
  • 00311917164298 ()

  • Height: 155 Millimeter
336146

  • Wart-removal cryogenic kit
Equate Freeze Wart Remover 18 applications
WAL-MART STORES, INC.
Wart Remover
In Commercial Distribution

  • 00194346121694 ()


  • Wart-removal cryogenic kit
The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9507-0
In Commercial Distribution

  • 00607158000069 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9505-1
In Commercial Distribution

  • 00607158000052 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 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) as described. One Vial containing 0.5mL 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 0.5mL 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 0.5mL 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.
60-9552-0
In Commercial Distribution

  • 00607158000045 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® 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.
60-9546-0
In Commercial Distribution

  • 00607158000038 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9523-0
Not in Commercial Distribution

  • 00607158000021 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
65-9500-0
In Commercial Distribution

  • 00607158000007 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
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
Cryogenic Wart remover
SCHOLL'S WELLNESS COMPANY LLC
90000335
In Commercial Distribution

  • 10888853002962 ()
  • 00888853002965 ()


  • Wart-removal cryogenic kit
Combination Cryogenic and Liquid Wart Remover
SCHOLL'S WELLNESS COMPANY LLC
90000336
In Commercial Distribution

  • 00888853002958 ()
  • 10888853002955 ()


  • Wart-removal cryogenic kit
Cryogenic wart remover kit
SCHOLL'S WELLNESS COMPANY LLC
90000336
In Commercial Distribution

  • 00888853001333 ()
  • 10888853001330 ()


  • Wart-removal cryogenic kit
Cryogenic wart remover
SCHOLL'S WELLNESS COMPANY LLC
90000072
In Commercial Distribution

  • 00888853000107 ()
  • 10888853000128 ()


  • Wart-removal cryogenic kit
CRYOTHERAPY H 2X88ML W/30 ARW&50 RND BDS
MEDLINE INDUSTRIES, INC.
OTCM170375
In Commercial Distribution

  • 10193489084818 ()
OTCM170375

  • Wart-removal cryogenic kit
CRYOTHERAPY H 88ML REPLACEMENT CANISTER
MEDLINE INDUSTRIES, INC.
OTCM170100
In Commercial Distribution

  • 10193489084795 ()
OTCM170100

  • Wart-removal cryogenic kit
CRYOTHERAPY V 236ML KIT 6 CONES+60 BUDS
MEDLINE INDUSTRIES, INC.
OTCM1501
In Commercial Distribution

  • 10193489084788 ()
OTCM1501

  • Wart-removal cryogenic kit
CRYOTHERAPY V 236ML REPLACEMENT CANISTER
MEDLINE INDUSTRIES, INC.
OTCM1500
In Commercial Distribution

  • 10193489084771 ()
OTCM1500

  • Wart-removal cryogenic kit
CRYOTHERAPY V 175ML KIT 6 CONES+60 BUDS
MEDLINE INDUSTRIES, INC.
OTCM1101
In Commercial Distribution

  • 10193489084764 ()
OTCM1101

  • Wart-removal cryogenic kit
MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests
Bio-RAD Laboratories, Inc.
25228
Not in Commercial Distribution

  • 00847865002745 ()

  • 50 Tests
25228

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Venowave VW5 series comprises compact, battery-operated non-pneumatic, non-sequential, peristaltic wave compression pumps designed to generate wave-form motion. When securely fastened below the knee on the calf, these pumps create compression, leading to an increased upward volumetric displacement of venous and lymph fluid. The device is used for Management of the symptoms of post thrombolytic syndrome (PTS), Prevention of deep vein thrombosis (DVT), Prevention of primary thrombosis, Treatment of lymphedema, Diminishing post-operative pain and swelling, Treatment of leg swelling due to vascular insufficiency, Treatment of varicose veins Treatment of chronic venous insufficiency.
Therma Bright Inc
VW5-6
In Commercial Distribution

  • 00627843553601 ()
  • 00627843553595 ()
  • 00683601000053 ()

  • Weight: 270 Gram
  • Length: 190 Millimeter
  • Width: 100 Millimeter
  • Height: 48 Millimeter


  • Wearable sequential venous compression system
Cryogenic Skin Tag Removal
Dgi Group LLC
AZ-6055
In Commercial Distribution

  • 00850001389242 ()


  • Wart-removal cryogenic kit
Cryogenic Skin Tag Remover
Dgi Group LLC
AZ-6055
In Commercial Distribution

  • 00850001389167 ()


  • Wart-removal cryogenic kit
Wart Freezer 1-Step Wart Remover
WAL-MART STORES, INC.
563008516
Not in Commercial Distribution

  • 20681131162702 ()
  • 00681131162708 ()

  • Height: 155 Millimeter
563008516

  • Wart-removal cryogenic kit
LEG GARMENT, DAYSPRING, LONG, RIGHT
Koya Medical, Inc.
F-0040-08
Not in Commercial Distribution

  • 00850012532798 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, LONG, LEFT
Koya Medical, Inc.
F-0040-07
Not in Commercial Distribution

  • 00850012532781 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, RIGHT
Koya Medical, Inc.
F-0040-06
Not in Commercial Distribution

  • 00850012532774 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, MEDIUM, LEFT
Koya Medical, Inc.
F-0040-05
Not in Commercial Distribution

  • 00850012532767 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, SHORT, RIGHT
Koya Medical, Inc.
F-0040-04
Not in Commercial Distribution

  • 00850012532750 ()


  • Wearable sequential venous compression system
LEG GARMENT, DAYSPRING, SHORT, LEFT
Koya Medical, Inc.
F-0040-03
Not in Commercial Distribution

  • 00850012532743 ()


  • Wearable sequential venous compression system
LOWER LEG GARMENT
Koya Medical, Inc.
F-0050-02
Not in Commercial Distribution

  • 00850012532736 ()


  • Wearable sequential venous compression system
ARM GARMENT, LONG
Koya Medical, Inc.
F-0010-09
Not in Commercial Distribution

  • 00850012532729 ()


  • Wearable sequential venous compression system
ARM GARMENT, MED
Koya Medical, Inc.
F-0010-08
Not in Commercial Distribution

  • 00850012532712 ()


  • Wearable sequential venous compression system
ARM GARMENT, SHORT
Koya Medical, Inc.
F-0010-07
Not in Commercial Distribution

  • 00850012532705 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, LONG
Koya Medical, Inc.
F-0010-06
In Commercial Distribution

  • 00850012532699 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, MEDIUM
Koya Medical, Inc.
F-0010-05
In Commercial Distribution

  • 00850012532682 ()


  • Wearable sequential venous compression system
ARM GARMENT, DAYSPRING, SHORT
Koya Medical, Inc.
F-0010-04
In Commercial Distribution

  • 00850012532675 ()


  • Wearable sequential venous compression system
CONTROLLER, DAYSPRING, LITE
Koya Medical, Inc.
F-0085-01
In Commercial Distribution

  • 00850012532651 ()
F-0085-01

  • Wearable sequential venous compression system
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