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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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ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control
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
Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

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

  • Voice amplification system
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
COE® Check-Bite™ #72, Unilateral, Non-Water Cooled
Gc America Inc.
267201
In Commercial Distribution

  • D6582672012 ()
  • D6582672011 ()
  • D6582672014 ()
  • D6582672010 ()
267201

  • Dental impression tray, reusable
COE® Check-Bite™ #70, Unilateral, Water Cooled, for Hydrocolloid
Gc America Inc.
267001
In Commercial Distribution

  • D6582670012 ()
  • D6582670011 ()
  • D6582670014 ()
  • D6582670010 ()
267001

  • Dental impression tray, reusable
COE® Stainless Steel-Perforated Partials Individual Tray #S33 Anterior Upper
Gc America Inc.
264331
In Commercial Distribution

  • D6582643314 ()
  • D6582643312 ()
  • D6582643311 ()
264331

  • Dental impression tray, reusable
COE® Stainless Steel-Perforated Partials Individual Trays #S32 Anterior Lower
Gc America Inc.
264321
In Commercial Distribution

  • D6582643212 ()
  • D6582643211 ()
  • D6582643214 ()
264321

  • Dental impression tray, reusable
COE® Stainless Steel-Perforated Partials Individual Trays #S30 Right Unilateral
Gc America Inc.
264301
In Commercial Distribution

  • D6582643014 ()
  • D6582643012 ()
  • D6582643011 ()
264301

  • Dental impression tray, reusable
COE® Stainless Steel-Perforated Individual Tray #S22 Lower
Gc America Inc.
264221
In Commercial Distribution

  • D6582642214 ()
  • D6582642212 ()
  • D6582642211 ()
264221

  • Dental impression tray, reusable
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