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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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LAMAZE JD Chill Teether
TOMY INTERNATIONAL, INC.
L27412
In Commercial Distribution

  • B268L274120 ()
  • B268L274122 ()
  • B268L274128 ()
  • B268L274129 ()
L27412

  • Teething device, fluid-filled
BOON Care Health Kit (Thermometer)
TOMY INTERNATIONAL, INC.
B11185
In Commercial Distribution

  • B268B111859 ()
  • B268B111854 ()
  • B268B111851 ()
  • B268B111850 ()


  • Infant care kit
Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7957
In Commercial Distribution

  • B268Y79571 ()
  • B26879570 ()
  • B268Y79573 ()
  • B268Y79579 ()
Y7957

  • Infant care kit
Polyp Trap with screw top, fine-mesh screen and tube with connector.. Package of 10.
M D Technologies Inc.
PT20C-10
In Commercial Distribution

  • B325PT20C100 ()
  • B325PT20C101 ()
  • B325PT20C252 ()
  • B325PT20C503 ()
  • B325PT20C1004 ()
PT20C10

  • Surgical suction system collection container, single-use
Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.
M D Technologies Inc.
PT20-10
In Commercial Distribution

  • B325PT20252 ()
  • B325PT20100 ()
  • B325PT20503 ()
  • B325PT201004 ()
  • B325PT20101 ()
PT2010

  • Surgical suction system collection container, single-use
LARGE ELECTRODE PAD
BEAR DOWN CONSULTING
PEPADBFLY
In Commercial Distribution

  • B311PEPADBFLY1 ()
  • B311PEPADBFLY0 ()
  • B311PEPADBFLY2 ()
  • B311PEPADBFLY3 ()


  • Transcutaneous electrical stimulation electrode, single-use
Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
BIO-MED DIAGNOSTICS, INC.
1080
In Commercial Distribution

  • B08810804 ()
  • B08810800 ()
  • B08810802 ()
  • B08810803 ()
10-8000

  • Neisseria gonorrhoeae culture isolate identification IVD, kit
S-CRYOLOCK - YELLOW - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (Y)
In Commercial Distribution

  • B056SCLY5 ()
  • B056SCLY2 ()
  • B056SCLY1 ()
  • B056SCLY0 ()
  • B056SCLY3 ()
S-CL (YELLOW)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (O)
In Commercial Distribution

  • B056SCLO5 ()
  • B056SCLO2 ()
  • B056SCLO1 ()
  • B056SCLO0 ()
  • B056SCLO3 ()
S-CL (ORANGE)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (G)
In Commercial Distribution

  • B056SCLG5 ()
  • B056SCLG2 ()
  • B056SCLG1 ()
  • B056SCLG0 ()
  • B056SCLG3 ()
S-CL (GREEN)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (C)
In Commercial Distribution

  • B056SCLC5 ()
  • B056SCLC2 ()
  • B056SCLC1 ()
  • B056SCLC0 ()
  • B056SCLC3 ()
S-CL (CLEAR)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (B)
In Commercial Distribution

  • B056SCLB5 ()
  • B056SCLB2 ()
  • B056SCLB1 ()
  • B056SCLB0 ()
  • B056SCLB3 ()
S-CL (BLUE)

  • Assisted reproduction vitrification carrier
NEEDLE,23 X 1
American Health Service Sales Corporation
AHS2325RN
In Commercial Distribution

  • B031AHS2325RN2 ()
  • B031AHS2325RN1 ()
  • B031AHS2325RN0 ()
  • B031AHS2325RN3 ()


  • Hypodermic needle, single-use
Permanent Tissue-Integrating Surgical Matrix
CORNEAT VISION LTD
1007691
In Commercial Distribution

  • G16010362951 ()
  • G16010362950 ()
  • G16010362952 ()

  • 5.0 mm X 6.5 mm X 100 um
1036295

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Wallmax Aneroid Sphygmomanometer
GF HEALTH PRODUCTS, INC.
222
In Commercial Distribution

  • M3682223 ()
  • M3682222 ()
  • M3682221 ()


  • Aneroid manual sphygmomanometer
Digital Ear Thermometer
GF HEALTH PRODUCTS, INC.
2215
In Commercial Distribution

  • M36822153 ()
  • M36822152 ()
  • M36822151 ()


  • Intermittent electronic patient thermometer
Digital Thermometer
GF HEALTH PRODUCTS, INC.
2214.CE
In Commercial Distribution

  • M3682214CE3 ()
  • M3682214CE2 ()
  • M3682214CE1 ()


  • Intermittent electronic patient thermometer
Digital Thermometer
GF HEALTH PRODUCTS, INC.
2210
In Commercial Distribution

  • M36822101 ()
  • M36822102 ()
  • M36822103 ()


  • Intermittent electronic patient thermometer
Advanced Wrist Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
1147
In Commercial Distribution

  • M36811472 ()
  • M36811471 ()
  • M36811473 ()


  • Patient monitoring system module, blood pressure, noninvasive
Digital Talking Wrist Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
1146
In Commercial Distribution

  • M36811463 ()
  • M36811462 ()
  • M36811461 ()


  • Patient monitoring system module, blood pressure, noninvasive
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