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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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ARROW - 30801902092169

AUTOCAT2 WAVE SPANISH
TELEFLEX INCORPORATED
IPN000322
In Commercial Distribution

  • 30801902092169 ()
  • 00801902092168 ()
IAP-0500E

  • Intra-aortic balloon pump

ARROW - 30801902092145

AEROAUTOCAT2 DUTCH
TELEFLEX INCORPORATED
IPN000318
In Commercial Distribution

  • 30801902092145 ()
  • 00801902092144 ()
IAP-0435NL

  • Intra-aortic balloon pump

ARROW - 30801902092121

AEROAUTOCAT2 ITALIAN
TELEFLEX INCORPORATED
IPN000316
In Commercial Distribution

  • 30801902092121 ()
  • 00801902092120 ()
IAP-0435I

  • Intra-aortic balloon pump

ARROW - 30801902092107

AEROAUTOCAT2 GERMAN
TELEFLEX INCORPORATED
IPN000313
In Commercial Distribution

  • 30801902092107 ()
  • 00801902092106 ()
IAP-0435D

  • Intra-aortic balloon pump

ARROW - 30801902092091

N/A
TELEFLEX INCORPORATED
IPN000314
In Commercial Distribution

  • 30801902092091 ()
  • 00801902092090 ()
IAP-0435E

  • Intra-aortic balloon pump

ARROW - 30801902092084

AUTOCAT2 SWEDISH
TELEFLEX INCORPORATED
IPN000310
In Commercial Distribution

  • 30801902092084 ()
  • 00801902092083 ()
IAP-0400SV

  • Intra-aortic balloon pump

ARROW - 30801902092077

AUTOCAT2 DUTCH
TELEFLEX INCORPORATED
IPN000309
In Commercial Distribution

  • 30801902092077 ()
  • 00801902092076 ()
IAP-0400NL

  • Intra-aortic balloon pump

ARROW - 30801902092053

AUTOCAT2 FRENCH
TELEFLEX INCORPORATED
IPN000306
In Commercial Distribution

  • 30801902092053 ()
  • 00801902092052 ()
IAP-0400F

  • Intra-aortic balloon pump

ARROW - 30801902092039

AUTOCAT2 SPANISH
TELEFLEX INCORPORATED
IPN000305
In Commercial Distribution

  • 30801902092039 ()
  • 00801902092038 ()
IAP-0400E

  • Intra-aortic balloon pump

ARROW - 30801902091797

AEROAUTOCAT2 WAVE DUTCH
TELEFLEX INCORPORATED
IPN000335
In Commercial Distribution

  • 30801902091797 ()
  • 00801902091796 ()
IAP-0535NL

  • Intra-aortic balloon pump

ARROW - 30801902091773

AEROAUTOCAT2 WAVE ITALIAN
TELEFLEX INCORPORATED
IPN000333
In Commercial Distribution

  • 30801902091773 ()
  • 00801902091772 ()
IAP-0535I

  • Intra-aortic balloon pump

ARROW - 30801902091766

AEROAUTOCAT2 WAVE FRENCH
TELEFLEX INCORPORATED
IPN000332
In Commercial Distribution

  • 30801902091766 ()
  • 00801902091765 ()
IAP-0535F

  • Intra-aortic balloon pump

ARROW - 30801902091742

AEROAUTOCAT2 WAVE SPANISH
TELEFLEX INCORPORATED
IPN000331
In Commercial Distribution

  • 30801902091742 ()
  • 00801902091741 ()
IAP-0535E

  • Intra-aortic balloon pump

ARROW - 30801902091728

AUTOCAT2 WAVE DUTCH
TELEFLEX INCORPORATED
IPN000326
In Commercial Distribution

  • 30801902091728 ()
  • 00801902091727 ()
IAP-0500NL

  • Intra-aortic balloon pump

ARROW - 30801902051739

AEROAUTOCAT 2 WAVE
TELEFLEX INCORPORATED
IPN000329
In Commercial Distribution

  • 30801902051739 ()
  • 00801902051738 ()
IAP-0535

  • Intra-aortic balloon pump

ARROW - 30801902051722

AUTOCAT 2
TELEFLEX INCORPORATED
IPN000302
In Commercial Distribution

  • 30801902051722 ()
  • 00801902051721 ()
IAP-0400

  • Intra-aortic balloon pump

ARROW - 30801902043420

AUTOCAT2 WAVE JAPANESE
TELEFLEX INCORPORATED
IPN000325
In Commercial Distribution

  • 30801902043420 ()
  • 00801902043429 ()
IAP-0500J

  • Intra-aortic balloon pump

ARROW - 30801902043413

AUTOCAT2 JAPANESE
TELEFLEX INCORPORATED
IPN000308
In Commercial Distribution

  • 30801902043413 ()
  • 00801902043412 ()
IAP-0400J

  • Intra-aortic balloon pump

SANDBAG 5 LB 5" X 12" - 00733657240795

No Description
ALIMED, INC.
936924
In Commercial Distribution

  • 00733657240795 ()
2970014619

  • Freestanding patient positioner, reusable

MANUKAhd Lite 5 x 5 cm - 05060188820581

No Description
MANUKAMED LIMITED PARTNERSHIP
MM0013
In Commercial Distribution

  • 05060188820574 ()
  • 05060188820581 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial

MANUKAhd Lite 5 x 5 cm - 05060188820062

No Description
MANUKAMED LIMITED PARTNERSHIP
MM0030
In Commercial Distribution

  • 05060188820055 ()
  • 05060188820062 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial

Cytokeratin 5/6 (CK 5/6) - 00847627008862

No Description
BIOCARE MEDICAL LLC
IPI105G10
In Commercial Distribution

  • 00847627008862 ()


  • Cytokeratin IVD, antibody

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

No Description
BIOCARE MEDICAL LLC
OPAI105T60
In Commercial Distribution

  • 00847627029096 ()


  • Cytokeratin IVD, antibody

Cytokeratin 5/6 (CK 5/6) - 00847627024626

No Description
BIOCARE MEDICAL LLC
AVI105G
In Commercial Distribution

  • 00847627024626 ()


  • Cytokeratin IVD, antibody

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016285

CELL SAVER 5/5+ BOWL KIT-70ML
HAEMONETICS CORPORATION
0291E-00
In Commercial Distribution

  • 30812747016289 ()
  • 10812747016285 ()

  • Total Volume: 70 Milliliter
  • Total Volume: 1000 Milliliter
  • Total Volume: 5 Liter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016483

SEQUESTRATION SET
HAEMONETICS CORPORATION
00244-00
In Commercial Distribution

  • 30812747016487 ()
  • 10812747016483 ()

  • Total Volume: 600 Milliliter
  • Total Volume: 1000 Milliliter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEM - 10812747016278

CS5/5+ FASTPACK, 125ML 20µ RES
HAEMONETICS CORPORATION
0265F-00
Not in Commercial Distribution

  • 30812747016272 ()
  • 10812747016278 ()

  • Total Volume: 125 Milliliter
  • Pore Size: 20 Micrometer
  • Total Volume: 10 Liter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEM - 10812747016261

CS5/5+ FASTPACK,225ML, 20µ RES
HAEMONETICS CORPORATION
0260F-00
Not in Commercial Distribution

  • 30812747016265 ()
  • 10812747016261 ()

  • Total Volume: 225 Milliliter
  • Pore Size: 20 Micrometer


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016131

CELL SAVER 5/5+ BOWL KIT-225ML
HAEMONETICS CORPORATION
00263-00
In Commercial Distribution

  • 30812747016135 ()
  • 10812747016131 ()

  • Total Volume: 10 Liter
  • Total Volume: 1000 Milliliter
  • Total Volume: 225 Milliliter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016124

CELL SAVER 5/5+ BOWL KIT-125ML
HAEMONETICS CORPORATION
00261-00
In Commercial Distribution

  • 30812747016128 ()
  • 10812747016124 ()

  • Total Volume: 10 Liter
  • Total Volume: 125 Milliliter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016117

CS5/5+ FASTPACK, 225ML 150U RES
HAEMONETICS CORPORATION
00260-00
In Commercial Distribution

  • 30812747016111 ()
  • 10812747016117 ()

  • Pore Size: 150 Micrometer
  • Total Volume: 225 Milliliter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEMS - 10812747016100

10 LITER WASTE BAG
HAEMONETICS CORPORATION
00246-00
In Commercial Distribution

  • 30812747016104 ()
  • 20812747016107 ()
  • 10812747016100 ()

  • Total Volume: 10 Liter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEM - 10812747015172

CELL SAVER 5/5+ BOWL SET (70ML)
HAEMONETICS CORPORATION
0291A-00
In Commercial Distribution

  • 10812747015172 ()
  • 30812747015176 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 5 Liter
  • Total Volume: 70 Milliliter


  • Autotransfusion system blood component processing set

HAEMONETICS CELL SAVER 5/5+ SYSTEM - 10812747015165

HIGH SPEED CELL SAVER5/5+BOWL SET
HAEMONETICS CORPORATION
0263A-00
In Commercial Distribution

  • 30812747015169 ()
  • 10812747015165 ()

  • Total Volume: 225 Milliliter
  • Total Volume: 10 Liter
  • Total Volume: 1000 Milliliter


  • Autotransfusion system blood component processing set

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

Serial Data Com. Cable Recording-/CARTO® Systems - 04260166371499

No Description
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable

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

No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable

SpO2.COM™ SpO2 disposable sensor sample pack - 10843997010358

No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use
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