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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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Brasseler USA - 00887919805656

A637BLACK CD ST-GABRIEL-BRANDON
Peter Brasseler Holdings, LLC
5026605U0
In Commercial Distribution

  • 00887919805656 ()


  • Diamond dental bur, single-use

Ceramage - E23518020

Ceramage CD Set
SHOFU DENTAL CORPORATION
1802
In Commercial Distribution

  • E23518020 ()
1802

  • Dental prosthesis veneer resin

Dexcom Studio - 00386270000149

Dexcom Studio CD
Dexcom, Inc.
MT21360
In Commercial Distribution

  • 00386270000149 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

CD-Chex Plus BC - 00844509000549

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of CD4L and Normal level.
STRECK, INC.
213376
In Commercial Distribution

  • 00844509000549 ()

  • Total Volume: 3.0 Milliliter
213376

  • Multiple CD cell marker IVD, control

CD-Chex Plus BC - 00844509000532

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of CD4L and Normal level.
STRECK, INC.
213375
Not in Commercial Distribution

  • 00844509000532 ()

  • Total Volume: 3.0 Milliliter
213375

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 00844509000501

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 2 vials each of level 1 and 2.
STRECK, INC.
213339
In Commercial Distribution

  • 00844509000501 ()

  • Total Volume: 1.0 Milliliter
213339

  • Multiple CD cell marker IVD, control

CD-Chex CD34 - 00844509000495

A positive procedural control for enumerating CD34 positive cells by flow cytometry. Contains 1 vial each of level 1 and 2.
STRECK, INC.
213338
In Commercial Distribution

  • 00844509000495 ()

  • Total Volume: 1.0 Milliliter
213338

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 00844509000174

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial each of levels CD4L and Normal.
STRECK, INC.
213391
In Commercial Distribution

  • 00844509000174 ()

  • Total Volume: 3.0 Milliliter
213391

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 00844509000167

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials each of levels CD4L and Normal.
STRECK, INC.
213370
In Commercial Distribution

  • 00844509000167 ()

  • Total Volume: 3.0 Milliliter
213370

  • Multiple CD cell marker IVD, control

CD-Chex Plus - 00844509000150

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vials each of levels CD4L and Normal.
STRECK, INC.
213369
In Commercial Distribution

  • 00844509000150 ()

  • Total Volume: 3.0 Milliliter
213369

  • Multiple CD cell marker IVD, control
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