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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
LARGE ELECTRODE PAD
BEAR DOWN CONSULTING
PEPADBFLY
In Commercial Distribution

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


  • Transcutaneous electrical stimulation electrode, single-use
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
Flo2Max 5-in-1 Oxygen Mask, Child
B.L.S. Systems Limited
6110
In Commercial Distribution

  • B00266107 ()
  • B00261100 ()
  • B00261109 ()
  • B00261107 ()

  • Child
6110

  • Non-rebreathing oxygen face mask
The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-1012XL
In Commercial Distribution

  • M7298001012XL2 ()
  • M7298001012XL0 ()
  • M7298001012XL1 ()
  • M7298001012XL3 ()

  • Catheter Gauge: 10 to 12 French


  • Femoral artery closure plug/patch, collagen
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