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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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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
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
Collection Assist Device that collects a clean sample from the female hansen port of a hemodialysis machine.
MOLDED PRODUCTS, INC.
MPC-745
In Commercial Distribution

  • B144MPC7451 ()
  • B144MPC7450 ()
  • B144MPC7452 ()
  • B144MPC7453 ()
MPC-745

  • Haemodialysis treatment kit
Luer Lock Cap Set - (1) Red and (1) Blue per set
MOLDED PRODUCTS, INC.
MPC-125
In Commercial Distribution

  • B144MPC1251 ()
  • B144MPC1250 ()
  • B144MPC1252 ()
  • B144MPC1254 ()
MPC-125

  • Luer-formatted disinfection cap
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