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

Show Filters

100SH 8X10IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046272 ()
  • 40889976046278 ()
  • 00889976046270 ()
6046270

  • Medical x-ray film, non-screen
100SH 11X14IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046265 ()
  • 40889976046261 ()
  • 00889976046263 ()
6046262

  • Medical x-ray film, non-screen
100SH 5X12IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046258 ()
  • 40889976046254 ()
  • 00889976046256 ()
6046254

  • Medical x-ray film, non-screen
100SH 15X30-6X12 DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
Not in Commercial Distribution

  • 60889976046241 ()
  • 40889976046247 ()
  • 00889976046249 ()
6046247

  • Medical x-ray film, non-screen
25SH 14X36IN E BLUE X-RAY WB (TRPL)
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976046043 ()
  • 40889976046049 ()
  • 00889976046041 ()
6046049

  • Medical x-ray film, screen
100SH 24X24 (9.5X9.5) E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976046029 ()
  • 40889976046025 ()
  • 00889976046027 ()
6046023

  • Medical x-ray film, screen
100SH 10X12IN E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976045992 ()
  • 40889976045998 ()
  • 00889976045990 ()
6045991

  • Medical x-ray film, screen
25SH 14X36IN E GREEN X-RAY WB (TRPL)
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045961 ()
  • 40889976045967 ()
  • 00889976045969 ()
6045967

  • Medical x-ray film, screen
100SH 18X24CM E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976045947 ()
  • 40889976045943 ()
  • 00889976045945 ()
6045942

  • Medical x-ray film, screen
100SH 24X30CM E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045930 ()
  • 40889976045936 ()
  • 00889976045938 ()
6045934

  • Medical x-ray film, screen
100SH 30X35CM E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976045923 ()
  • 40889976045929 ()
  • 00889976045921 ()
6045926

  • Medical x-ray film, screen
100SH 8X10IN E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045909 ()
  • 40889976045905 ()
  • 00889976045907 ()
6045900

  • Medical x-ray film, screen
100SH 10X12IN E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976045893 ()
  • 40889976045899 ()
  • 00889976045891 ()
6045892

  • Medical x-ray film, screen
100SH 11X14IN E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045886 ()
  • 40889976045882 ()
  • 00889976045884 ()
6045884

  • Medical x-ray film, screen
100SH 24X24 (9.5X9.5) E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045879 ()
  • 40889976045875 ()
  • 00889976045877 ()
6045876

  • Medical x-ray film, screen
100SH 13X18 (5X7) E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045862 ()
  • 40889976045868 ()
  • 00889976045860 ()
6045868

  • Medical x-ray film, screen
100SH 18X43 (7X17) E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
In Commercial Distribution

  • 60889976045855 ()
  • 40889976045851 ()
  • 00889976045853 ()
6045850

  • Medical x-ray film, screen
100SH 35X43 (14X17) E GREEN X-RAY WB
CARESTREAM HEALTH, INC.
E Green X-ray Film WB
Not in Commercial Distribution

  • 60889976045848 ()
  • 40889976045844 ()
  • 00889976045846 ()
6045843

  • Medical x-ray film, screen
100SH 35X43-14X17 E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045619 ()
  • 40889976045615 ()
  • 00889976045617 ()
6045611

  • Medical x-ray film, screen
100SH 35X35-14X14 E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045602 ()
  • 40889976045608 ()
  • 00889976045600 ()
6045603

  • Medical x-ray film, screen
100SH 30X40CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045596 ()
  • 40889976045592 ()
  • 00889976045594 ()
6045595

  • Medical x-ray film, screen
100SH 20X40CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045572 ()
  • 40889976045578 ()
  • 00889976045570 ()
6045579

  • Medical x-ray film, screen
100SH 18X24CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045565 ()
  • 40889976045561 ()
  • 00889976045563 ()
6045561

  • Medical x-ray film, screen
100SH 15X40CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
Not in Commercial Distribution

  • 60889976045558 ()
  • 40889976045554 ()
  • 00889976045556 ()
6045553

  • Medical x-ray film, screen
100SH 13X18CM E BLUE X-RAY WB
CARESTREAM HEALTH, INC.
E Blue X-ray Film WB
In Commercial Distribution

  • 60889976045534 ()
  • 40889976045530 ()
  • 00889976045532 ()
6045538

  • Medical x-ray film, screen
25SH 14X36IN GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971946270 ()
  • 40889971946276 ()
  • 00889971946278 ()
1946276

  • Medical x-ray film, screen
100SH 10X12IN GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971753229 ()
  • 40889971753225 ()
  • 00889971753227 ()
1753227

  • Medical x-ray film, screen
100SH 30X35CM GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971706225 ()
  • 40889971706221 ()
  • 00889971706223 ()
1706225

  • Medical x-ray film, screen
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of high level.
STRECK, INC.
215436
In Commercial Distribution

  • 40844509000707 ()

  • Total Volume: 1.5 Milliliter
215436

  • Full blood count IVD, control
100SH 11X14IN BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
Not in Commercial Distribution

  • 60889971878663 ()
  • 40889971878669 ()
  • 00889971878661 ()
1878669

  • Medical x-ray film, screen
25SH 14X36IN BLUE X-RAY WB
CARESTREAM HEALTH, INC.
Full Blue X-ray Film WB
In Commercial Distribution

  • 60889971860101 ()
  • 40889971860107 ()
  • 00889971860109 ()
1860105

  • Medical x-ray film, screen
100SH 35X43-14X17 DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
In Commercial Distribution

  • 60889971354440 ()
  • 40889971354446 ()
  • 00889971354448 ()
1354448

  • Medical x-ray film, non-screen
100SH 35X35-14X14 GREEN X-RAY WB 8389
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971096210 ()
  • 40889971096216 ()
  • 00889971096218 ()
1096213

  • Medical x-ray film, screen
100SH 11X14IN GREEN X-RAY WB
CARESTREAM HEALTH, INC.
Green X-ray Film WB
In Commercial Distribution

  • 60889971084477 ()
  • 40889971084473 ()
  • 00889971084475 ()
1084474

  • Medical x-ray film, screen
100SH 10X12IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
In Commercial Distribution

  • 60889971043214 ()
  • 40889971043210 ()
  • 00889971043212 ()
1043215

  • Medical x-ray film, non-screen
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of normal level.
STRECK, INC.
215416
In Commercial Distribution

  • 40844509000691 ()

  • Total Volume: 1.5 Milliliter
215416

  • Full blood count IVD, control
A multi-parameter hematology control for small laboratories and point-of-care applications that perform a limited number of hematology tests. Contains 6 vials of low level.
STRECK, INC.
215426
In Commercial Distribution

  • 40844509000684 ()

  • Total Volume: 1.5 Milliliter
215426

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of high level.
STRECK, INC.
218753
In Commercial Distribution

  • 40844509000639 ()

  • Total Volume: 2.5 Milliliter
218753

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 1 vial of low level.
STRECK, INC.
218751
In Commercial Distribution

  • 40844509000622 ()

  • Total Volume: 2.5 Milliliter
218751

  • Full blood count IVD, control
A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of normal level.
STRECK, INC.
218995
In Commercial Distribution

  • 40844509000615 ()

  • Total Volume: 4.5 Milliliter
218995

  • Full blood count IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
STRECK, INC.
213377
In Commercial Distribution

  • 40844509000523 ()

  • Total Volume: 3.0 Milliliter
213377

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of Normal level.
STRECK, INC.
213378
In Commercial Distribution

  • 40844509000516 ()

  • Total Volume: 3.0 Milliliter
213378

  • Multiple CD cell marker IVD, control
A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
STRECK, INC.
221108
In Commercial Distribution

  • 40844509000318 ()

  • Total Volume: 3.0 Milliliter
221108

  • Full blood count IVD, calibrator
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level CD4L
STRECK, INC.
213324
In Commercial Distribution

  • 40844509000141 ()

  • Total Volume: 3.0 Milliliter
213324

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level Normal
STRECK, INC.
213323
In Commercial Distribution

  • 40844509000134 ()

  • Total Volume: 3.0 Milliliter
213323

  • Multiple CD cell marker IVD, control
A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 8 vials Normal level.
STRECK, INC.
213333
In Commercial Distribution

  • 40844509000080 ()

  • Total Volume: 2.5 Milliliter
213333

  • Multiple CD cell marker IVD, control
ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle
MICERIUM SPA
CPCK
In Commercial Distribution

  • EMICCPCK1 ()
CPCK

  • Glass ionomer dental cement
  • Dental prosthesis-component adhesive
ENA-BOND SE KIT Bonding + Primer -1 CFOTS-2 (2 ml) -1 CFOTP-2 (2 ml)
MICERIUM SPA
CFOTX
In Commercial Distribution

  • EMICCFOTX1 ()

  • Total Volume: 4 Milliliter
CFOTX

  • Dentine bonding agent/set
ENA-BOND SE LIGHT CURING BONDING 2 ml
MICERIUM SPA
CFOTS-2
In Commercial Distribution

  • EMICCFOTS20 ()

  • Total Volume: 2 Milliliter
CFOTS-2

  • Dentine bonding agent/set
ENA-BOND SE LIGHT CURING BONDING 5 ml
MICERIUM SPA
CFOTS
In Commercial Distribution

  • EMICCFOTS1 ()

  • Total Volume: 5 Milliliter
CFOTS

  • Dentine bonding agent/set
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