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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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Welldoc - B553202254RX0

Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution

  • B553202254RX0 ()


  • Home pharmaceutical management support software

Welldoc - B553202253OTC0

Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution

  • B553202253OTC0 ()


  • Home pharmaceutical management support software

Welldoc - B553202252RX0

Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution

  • B553202252RX0 ()


  • Home pharmaceutical management support software

Welldoc - B553202251OTC0

Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions.
WELLDOC, INC.
3.X
Not in Commercial Distribution

  • B553202251OTC0 ()


  • Home pharmaceutical management support software

LDV Syringe 1mL/cc x 1FT x FDN38 (23G x 38.1mm) - 08800145513821

No Description
Feeltech Co.,Ltd.
1FT x FDN38
In Commercial Distribution

  • 18800145513828 ()
  • 08800145513821 ()
  • 28800145513825 ()


  • General-purpose syringe/needle

LDV Syringe 1mL/cc x 1FT x FDN37 (25G x 38.1mm) - 08800145513814

No Description
Feeltech Co.,Ltd.
1FT x FDN37
In Commercial Distribution

  • 18800145513811 ()
  • 08800145513814 ()
  • 28800145513818 ()


  • General-purpose syringe/needle

LDV Syringe 1mL/cc x 1FT x FDN24 (25G x 25.4mm) - 08800145513807

No Description
Feeltech Co.,Ltd.
1FT x FDN24
In Commercial Distribution

  • 18800145513804 ()
  • 08800145513807 ()
  • 28800145513801 ()


  • General-purpose syringe/needle

LDV Syringe 1mL/cc x 1FT x FDN3 (23G x 25mm) - 08800145513791

No Description
Feeltech Co.,Ltd.
1FT x FDN3
In Commercial Distribution

  • 18800145513798 ()
  • 08800145513791 ()
  • 28800145513795 ()


  • General-purpose syringe/needle

LensHooke X QC Video (For Semen) - 04719874741099

No Description
BONRAYBIO CO., LTD.
QXB set package-US HT
In Commercial Distribution

  • 04719874741099 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741082

No Description
BONRAYBIO CO., LTD.
QXB set package-US BR
In Commercial Distribution

  • 04719874741082 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741051

No Description
BONRAYBIO CO., LTD.
QXB V2 package
In Commercial Distribution

  • 04719874741051 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741044

No Description
BONRAYBIO CO., LTD.
QXB V1 package
In Commercial Distribution

  • 04719874741044 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Video (For Semen) - 04719874741037

No Description
BONRAYBIO CO., LTD.
QXB V0 package
In Commercial Distribution

  • 04719874741037 ()
X QC Video

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740900

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L2_BR USA CORP.
In Commercial Distribution

  • 04719874740900 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740894

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L1_BR USA CORP.
In Commercial Distribution

  • 04719874740894 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740887

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L0_BR USA CORP.
In Commercial Distribution

  • 04719874740887 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740870

04719874740887 LensHooke X QC Reticle (For Semen)-L0 04719874740894 LensHooke X QC Reticle (For Semen)-L1 04719874740900 LensHooke X QC Reticle (For Semen)-L2 For BR USA CORP.
BONRAYBIO CO., LTD.
X QC Reticle - 3 in1_BR USA CORP.
In Commercial Distribution

  • 04719874740870 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740863

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L2_US
In Commercial Distribution

  • 04719874740863 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740856

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L1_US
In Commercial Distribution

  • 04719874740856 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740849

No Description
BONRAYBIO CO., LTD.
X QC Reticle - L0_US
In Commercial Distribution

  • 04719874740849 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

LensHooke X QC Reticle (For Semen) - 04719874740832

04719874740849 LensHooke X QC Reticle (For Semen)- L0 04719874740856 LensHooke X QC Reticle (For Semen)- L1 04719874740863 LensHooke X QC Reticle (For Semen)- L2 For US
BONRAYBIO CO., LTD.
X QC Reticle - 3 in1_US
In Commercial Distribution

  • 04719874740832 ()
X QC Reticle

  • Sperm concentration indicator IVD, control

Intelliguides - G2710620340100

Quad Channel Met-Traverse, 34mm x 10mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution

  • G2710620340100 ()

  • Length: 34 Millimeter
  • Depth: 10 Millimeter
34mm x 10mm

  • Orthopaedic implant aiming/guiding block, single-use

Intelliguides - G2710620300140

Quad Channel Met-Traverse, 30mm x 14mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution

  • G2710620300140 ()

  • Length: 30 Millimeter
  • Depth: 14 Millimeter
30mm x 14mm

  • Orthopaedic implant aiming/guiding block, single-use

Intelliguides - G2710620300100

Quad Channel Met-Traverse, 30mm x 10mm
Mios Marketing, LLC
Met-Traverse
In Commercial Distribution

  • G2710620300100 ()

  • Length: 30 Millimeter
  • Depth: 10 Millimeter
30mm x 10mm

  • Orthopaedic implant aiming/guiding block, single-use

IPD - 08435566640353

IPDmilled Analog Ø 3,5-5,5 NEO 5.DIM.355
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566640353 ()
IPD/6A-AR-00/X

  • Dental implant analog

IPD - 08435566640346

IPDmilled Analog Ø 3,25 NEO 5.DIM.325
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566640346 ()
IPD/6A-AN-00/X

  • Dental implant analog

IPD - 08435566638046

IPDmilled Analog Ø 4,1 I 5.La4.100
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638046 ()
IPD/BA-AR-00/X

  • Dental implant analog

IPD - 08435566638039

IPDmilled Analog Ø 5,1 K 5.La5.100
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638039 ()
IPD/AA-AW-00/X

  • Dental implant analog

IPD - 08435566638022

IPDmilled Analog Ø 4,1 K 5.La4.100
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638022 ()
IPD/AA-AR-00/X

  • Dental implant analog

IPD - 08435566638015

IPDmilled Analog Ø 3,5 K 5.La3.500
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566638015 ()
IPD/AA-AN-00/X

  • Dental implant analog
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