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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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TFY Rapid Read Underarm Thermometer
TOMY INTERNATIONAL, INC.
Y7051
In Commercial Distribution

  • B268Y70514 ()
  • B268Y70516 ()
  • B268Y70511 ()
  • B268Y70510 ()


  • General-purpose patient temperature probe, reusable
Teether
TOMY INTERNATIONAL, INC.
Y5228L
In Commercial Distribution

  • B268Y5288L9 ()
  • B268Y5288L6 ()
  • B268Y5288L1 ()
  • B268Y5288L0 ()


  • Teething device, fluid-filled
Star Teether
TOMY INTERNATIONAL, INC.
Y5288
In Commercial Distribution

  • B268Y52880 ()
  • B268Y52281 ()
  • B268Y52886 ()
  • B268Y52889 ()


  • Teething device, fluid-filled
Water Filled Chill Teethers
TOMY INTERNATIONAL, INC.
L27619
In Commercial Distribution

  • B268L276198 ()
  • B268L276192 ()
  • B268L276190 ()
  • B268L276199 ()
L27619

  • Teething device, fluid-filled
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
Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
CELLERA LLC
30150
In Commercial Distribution

  • B492301500 ()
  • B492301501 ()
  • B492301502 ()
  • B492301503 ()
30150

  • Glucose IVD, kit, electrometry
Vitale Silicone Super-Absorbent Dressing, 3.5" x 4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20234
Not in Commercial Distribution

  • B492202343 ()
  • B492202342 ()
  • B492202341 ()
  • B492202340 ()
20234

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Silicone Foam Dressings, 6"x6", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20166
Not in Commercial Distribution

  • B492201663 ()
  • B492201661 ()
  • B492201660 ()
  • B492201662 ()
20166

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Silicone Foam Dressings, 4"x4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20144
Not in Commercial Distribution

  • B492201440 ()
  • B492201441 ()
  • B492201442 ()
  • B492201443 ()
20144

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Silicone Foam Dressings with Antibacterial Silver, 6"x6", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20066
In Commercial Distribution

  • B492200663 ()
  • B492200662 ()
  • B492200661 ()
  • B492200660 ()
20066

  • Exudate-absorbent dressing, non-gel, antimicrobial
Vitale Silicone Foam Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case, 4 cases/overpack
CELLERA LLC
20044
In Commercial Distribution

  • B492200442 ()
  • B492200441 ()
  • B492200440 ()
  • B492200443 ()
20044

  • Exudate-absorbent dressing, non-gel, antimicrobial
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
Diasol Sodium Bicarbonate Powder
DIASOL, INC.
BP10000- 25G / x25T
In Commercial Distribution

  • B467BP4525 ()
  • B467BP4525G3 ()
  • B467BP4524T2 ()
  • B4674525T1 ()
BP2/3 - BP9/10

  • Haemodialysis concentrate
ProVeilâ„¢ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeilâ„¢ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
PV4030
In Commercial Distribution

  • B130PV40301 ()
  • B130PV40300 ()
  • B130PV40302 ()
  • B130PV40303 ()
PV4030

  • Nerve guide, animal-derived
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