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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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COE® - D6582600911

COE® Pediatric Perforated Individual Tray, #9 Upper
Gc America Inc.
260091
In Commercial Distribution

  • D6582600912 ()
  • D6582600911 ()
  • D6582600914 ()
260091

  • Dental impression tray, reusable

COE® - D6582600711

COE® Regular-Perforated, Individual Tray, #7 Upper
Gc America Inc.
260071
In Commercial Distribution

  • D6582600714 ()
  • D6582600712 ()
  • D6582600711 ()
260071

  • Dental impression tray, reusable

COE® - D6582600511

COE® Regular-Perforated, Individual Tray, #5 Upper
Gc America Inc.
260051
In Commercial Distribution

  • D6582600514 ()
  • D6582600512 ()
  • D6582600511 ()
260051

  • Dental impression tray, reusable

COE® - D6582600411

COE® Regular-Perforated, Individual Tray, #4 Upper
Gc America Inc.
260041
In Commercial Distribution

  • D6582600414 ()
  • D6582600412 ()
  • D6582600411 ()
260041

  • Dental impression tray, reusable

COE® - D6582600311

COE® Regular Perforated Individual Tray, #3 Upper
Gc America Inc.
260031
In Commercial Distribution

  • D6582600312 ()
  • D6582600311 ()
  • D6582600314 ()
260031

  • Dental impression tray, reusable

Soviflex - B79510010

Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor

SPEAX Patch - B792FGN002

Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system

OLO CBC Test Kit - B787TK10

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
In Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count

XCELL - B708XCPSPC1200

XCELL PC Fluid Volume Reducer 120ml XC-PSPC-120
APEX BIOLOGIX , LLC
XC-PSPC-120
In Commercial Distribution

  • B708XCPSPC1201 ()
  • B708XCPSPC1200 ()
  • B708XCPSPC1202 ()


  • Haematological concentrate system preparation kit, platelet concentration

BUSULFAN 25 NG/ML - B800BUS25VPFCHLA0

BUSULFAN 25 NG/ML
UTAK LABORATORIES, INC.
BUS 25 V P F CHLA
In Commercial Distribution

  • B800BUS25VPFCHLA5 ()
  • B800BUS25VPFCHLA0 ()
  • B800BUS25VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 25 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
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