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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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Cytokeratin 5/6 (CK 5/6) - 00847627029096

No Description
BIOCARE MEDICAL LLC
OPAI105T60
In Commercial Distribution

  • 00847627029096 ()


  • Cytokeratin IVD, antibody

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016148

CS5/5+ FASTPACK, 125ML, 150µ RES
HAEMONETICS CORPORATION
00265-00
In Commercial Distribution

  • 30812747016142 ()
  • 10812747016148 ()

  • Total Volume: 125 Milliliter
  • Pore Size: 150 Micrometer
  • Total Volume: 10 Liter


  • Autotransfusion system blood component processing set

Biotem - 08800036204173

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system

Biotem - 08800036204166

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system

SpO2.COM™ SpO2 disposable sensor sample pack - 10843997010358

No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use

SpO2.COM® adult/neonatal SpO2 disposable sensor - 10843997000496

No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • Pulse oximeter probe, single-use

SpO2.COM® RS-1 adult SpO2 reusable sensor - 00843997000505

No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable

S&W - 10854661006294

ECG Electrodes
Leonhard Lang GmbH
FS-TB1 /5 -5
In Commercial Distribution

  • 30854661006298 ()
  • 20854661006291 ()
  • 10854661006294 ()
  • 00854661006297 ()
505

  • Electrocardiographic electrode, single-use

S&W - 10854661006201

ECG Electrodes
Leonhard Lang GmbH
FS-TB /5 -5
In Commercial Distribution

  • 30854661006205 ()
  • 20854661006208 ()
  • 10854661006201 ()
  • 00854661006204 ()
855

  • Electrocardiographic electrode, single-use

S&W - 10854661006010

ECG Electrodes
Leonhard Lang GmbH
FS-TB4 /5 -5
In Commercial Distribution

  • 30854661006014 ()
  • 20854661006017 ()
  • 10854661006010 ()
  • 00854661006013 ()
754/5

  • Electrocardiographic electrode, single-use
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