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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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E Blue X-ray Film WB - 40889976045998

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

E Green X-ray Film WB - 40889976045967

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

E Green X-ray Film WB - 40889976045943

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

E Green X-ray Film WB - 40889976045936

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

E Green X-ray Film WB - 40889976045929

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

E Green X-ray Film WB - 40889976045905

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

E Green X-ray Film WB - 40889976045899

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

E Green X-ray Film WB - 40889976045882

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

E Green X-ray Film WB - 40889976045875

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

E Green X-ray Film WB - 40889976045868

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

E Green X-ray Film WB - 40889976045851

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

E Green X-ray Film WB - 40889976045844

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

E Blue X-ray Film WB - 40889976045615

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

E Blue X-ray Film WB - 40889976045608

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

E Blue X-ray Film WB - 40889976045592

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

E Blue X-ray Film WB - 40889976045578

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

E Blue X-ray Film WB - 40889976045561

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

E Blue X-ray Film WB - 40889976045554

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

E Blue X-ray Film WB - 40889976045530

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

Green X-ray Film WB - 40889971946276

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

Full Blue X-ray Film WB - 40889971878669

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

Full Blue X-ray Film WB - 40889971860107

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

Green X-ray Film WB - 40889971753225

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

Green X-ray Film WB - 40889971706221

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

DUP Film WB - 40889971354446

100SH 35X43-14X17 DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
In Commercial Distribution

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

  • Medical x-ray film, non-screen

Green X-ray Film WB - 40889971096216

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

Green X-ray Film WB - 40889971084473

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

DUP Film WB - 40889971043210

100SH 10X12IN DUPLICATING WB
CARESTREAM HEALTH, INC.
DUP Film WB
In Commercial Distribution

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

  • Medical x-ray film, non-screen

STaK-Chex - 30844509001158

A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 4 vials of normal level.
STRECK, INC.
225514
In Commercial Distribution

  • 30844509001158 ()

  • Total Volume: 4.0 Milliliter
225514

  • Full blood count IVD, control

Para 4 - 30844509000700

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.
215108
In Commercial Distribution

  • 30844509000700 ()

  • Total Volume: 1.5 Milliliter
215108

  • Full blood count IVD, control

Para 4 - 30844509000694

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.
215107
In Commercial Distribution

  • 30844509000694 ()

  • Total Volume: 1.5 Milliliter
215107

  • Full blood count IVD, control

Para 4 - 30844509000687

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.
215106
In Commercial Distribution

  • 30844509000687 ()

  • Total Volume: 1.5 Milliliter
215106

  • Full blood count IVD, control

Para 12 Extend - 30844509000632

A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of high level.
STRECK, INC.
218994
In Commercial Distribution

  • 30844509000632 ()

  • Total Volume: 2.5 Milliliter
218994

  • Full blood count IVD, control

Para 12 Extend - 30844509000625

A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of low level.
STRECK, INC.
218993
In Commercial Distribution

  • 30844509000625 ()

  • Total Volume: 2.5 Milliliter
218993

  • Full blood count IVD, control

Para 12 Extend - 30844509000618

A Multi-Parameter Assayed Hematology Control for Instruments Offering a 3-Part Differential. Contains 6 vials of normal level.
STRECK, INC.
218758
In Commercial Distribution

  • 30844509000618 ()

  • Total Volume: 2.5 Milliliter
218758

  • Full blood count IVD, control

CD-Chex Plus BC - 30844509000526

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of CD4L level.
STRECK, INC.
213372
In Commercial Distribution

  • 30844509000526 ()

  • Total Volume: 3.0 Milliliter
213372

  • Multiple CD cell marker IVD, control

CD-Chex Plus BC - 30844509000519

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials of Normal level.
STRECK, INC.
213374
In Commercial Distribution

  • 30844509000519 ()

  • Total Volume: 3.0 Milliliter
213374

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 30844509000489

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials of level 3.
STRECK, INC.
213383
In Commercial Distribution

  • 30844509000489 ()

  • Total Volume: 1.0 Milliliter
213383

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 30844509000472

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials of level 2.
STRECK, INC.
213347
In Commercial Distribution

  • 30844509000472 ()

  • Total Volume: 1.0 Milliliter
213347

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 30844509000465

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials of level 1.
STRECK, INC.
213337
In Commercial Distribution

  • 30844509000465 ()

  • Total Volume: 1.0 Milliliter
213337

  • Multiple CD cell marker IVD, control

STaK-Chex Plus Retics - 30844509000335

A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 12 vials of normal level.
STRECK, INC.
225483
In Commercial Distribution

  • 30844509000335 ()

  • Total Volume: 4.5 Milliliter
225483

  • Full blood count IVD, control

Cal-Chex A Plus - 30844509000311

A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.
STRECK, INC.
221107
In Commercial Distribution

  • 30844509000311 ()

  • Total Volume: 3.0 Milliliter
221107

  • Full blood count IVD, calibrator

Cell-Chex - 30844509000267

Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials of L1-CC.
STRECK, INC.
212430
In Commercial Distribution

  • 30844509000267 ()

  • Total Volume: 2.0 Milliliter
212430

  • Full blood count IVD, control

Cal-Chex - 30844509000243

A hematology calibrator assayed for Beckman Coulter®, Abbott, Horiba Medical, HTI, and Mindray instruments. Contains 3 vials.
STRECK, INC.
221103
In Commercial Distribution

  • 30844509000243 ()

  • Total Volume: 3.0 Milliliter
221103

  • Full blood count IVD, calibrator

Para 12® Plus - 30844509000199

Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide a white blood cell differential.
STRECK, INC.
230592
In Commercial Distribution

  • 30844509000199 ()

  • Total Volume: 3.0 Milliliter
230592

  • Full blood count IVD, control

CD-Chex Plus - 30844509000144

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
STRECK, INC.
213368
In Commercial Distribution

  • 30844509000144 ()

  • Total Volume: 3.0 Milliliter
213368

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 30844509000137

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
STRECK, INC.
213367
In Commercial Distribution

  • 30844509000137 ()

  • Total Volume: 3.0 Milliliter
213367

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 30844509000090

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.
STRECK, INC.
213332
In Commercial Distribution

  • 30844509000090 ()

  • Total Volume: 2.5 Milliliter
213332

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 30844509000083

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials Normal level.
STRECK, INC.
213327
In Commercial Distribution

  • 30844509000083 ()

  • Total Volume: 2.5 Milliliter
213327

  • Multiple CD cell marker IVD, control

SEcure® - 00810000529551

SEcure® Dentin Shade Resin Cement 9g Syringe (with 10 Tips)
PARKELL, INC.
S274
In Commercial Distribution

  • 00810000529551 ()
S274

  • Dental composite resin
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