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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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FPPL Meijer SPS +/-
MEIJER, INC.
FPPL
Not in Commercial Distribution

  • 10713733896327 ()
  • 00713733896320 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
For ABO and RhD Blood grouping. Para ABO y RhD agrupación de la sangre. Not for use for screening purposes prior to transfusion No para uso en cribado antes de transfusion Dry format cards for ABO and /or RhD determination for the grouping of stabilized venous blood, capillary blood or washed resuspended red blood cells. For in vitro diagnostic use by professionals. Manual test for detection/confirmation of the presence or absence of antigens A, B and D on human red blood cells from two individuals per ELDONCARD 2521. For blood centers’, field hospitals preliminary blood group determination prior to conventional blood grouping using capillary blood, venous, or washed suspensions or diluted red blood cells. Not to be used for screening purposes prior to transfusion.
Eldon Biologicals A/S
504-37v01
In Commercial Distribution

  • 05713494002690 ()
504-37

  • ABO/Rh multiple blood grouping IVD, kit, agglutination
No Description
Brainscope Company, Inc.
99-1403-028
In Commercial Distribution

  • 00852745007130 ()
  • 00852745007093 ()


  • Noninvasive device battery charger
No Description
DETAX GmbH
02856
In Commercial Distribution

  • EDET028561 ()


  • Denture reliner, elastic, long-term
No Description
NXSTAGE MEDICAL, INC.
NX0153
In Commercial Distribution

  • M535NX01530 ()


  • Haemodialysis system, institutional/home-use
No Description
BISCO INC.
F-6104
Not in Commercial Distribution

  • D757F61040 ()

  • sixe text
F-6104

  • Dentine bonding agent/set
Dental application set for intraoral use
Diaswiss SA
1RootEX1.3inone
In Commercial Distribution

  • 07630049994829 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
One Mask™ Oxygen Mask Mask, Adapter, 79" (200cm) Oxygen Tubing w/Label
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411000427 ()
  • 10704411000426 ()
OM001

  • Nebulizing system delivery set, single-use
FPPL Publix DPS +/-
PUBLIX SUPER MARKETS, INC.
FPPL
Not in Commercial Distribution

  • 00041415024762 ()
  • 10041415024769 ()
  • 00633472000133 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
FPPL Equaline DPS +/- (ER)
SPD SWISS PRECISION DIAGNOSTICS GMBH
FPPL
In Commercial Distribution

  • 00041163250949 ()
  • 10041163250946 ()
  • 00633472000133 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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