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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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ACCURUN® - 00816784020031

ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0002
In Commercial Distribution

  • 00816784020031 ()
2000-0002

  • Multiple blood-borne virus antigen/antibody IVD, control

ACCURUN® - 00816784020024

ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0001
In Commercial Distribution

  • 00816784020024 ()
2000-0001

  • Multiple blood-borne virus antigen/antibody IVD, control

Lumipulse Infectious Disease Controls - 04987270235584

No Description
FUJIREBIO INC.
235584
In Commercial Distribution

  • 04987270235584 ()

  • Number of bottles per kit = 8
  • Total mLs per bottle = 3/3/2.5


  • Multiple blood-borne virus antigen/antibody IVD, control

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369236

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369236 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Clostridium Difficile Glutamate Dehydrogenase(GDH) and Toxin A/B Detection Kit ( - 06974849369229

No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369229 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical

SpO2.COM® NRC-P12 Patient Cable - 00843997001380

No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-180 Patient Cable - 00843997001359

No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable

Well Lead Extraction Bag - 06936881133770

Type B 800ml
Well Lead Medical Co.,Ltd
O02A020810
In Commercial Distribution

  • 16936881133777 ()
  • 06936881133770 ()
  • 26936881133774 ()


  • Surgical tissue/fluid collection bag

Well Lead Extraction Bag - 06936881133763

Type B 550ml
Well Lead Medical Co.,Ltd
O02A020510
In Commercial Distribution

  • 16936881133760 ()
  • 06936881133763 ()
  • 26936881133767 ()


  • Surgical tissue/fluid collection bag

CARDINAL HEALTH - 10195594238056

CRANIOTOMY B PACK
Cardinal Health 200, LLC
SNE11CBL10
In Commercial Distribution

  • 50195594238054 ()
  • 10195594238056 ()
SNE11CBL10

  • Craniotomy kit

CARDINAL HEALTH - 10195594249069

PAIN TRAY B
Cardinal Health 200, LLC
34A3181A
In Commercial Distribution

  • 50195594249067 ()
  • 10195594249069 ()
34A3181A

  • Peripheral anaesthesia single-administration set, medicated

CARDINAL HEALTH - 10195594009229

O B PACK
Cardinal Health 200, LLC
SMA34DLWM1
In Commercial Distribution

  • 50195594009227 ()
  • 10195594009229 ()
SMA34DLWM1

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327660666

O B PACK
MEDLINE INDUSTRIES, INC.
DYNJ85322A
In Commercial Distribution

  • 40195327660667 ()
  • 10195327660666 ()
DYNJ85322A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327677527

OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ903739K
In Commercial Distribution

  • 10195327677527 ()
DYNJ903739K

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327697006

HEART B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ53589G
In Commercial Distribution

  • 10195327697006 ()
DYNJ53589G

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327695446

LAVH PART B
MEDLINE INDUSTRIES, INC.
DYNJV0312D
In Commercial Distribution

  • 40195327695447 ()
  • 10195327695446 ()
DYNJV0312D

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594079918

CRANIOTOMY B PACK
Cardinal Health 200, LLC
SNE11CBLD9
In Commercial Distribution

  • 50195594079916 ()
  • 10195594079918 ()
SNE11CBLD9

  • Craniotomy kit

CARDINAL HEALTH - 10195594079567

O B PACK
Cardinal Health 200, LLC
SMA11OSCTN
In Commercial Distribution

  • 50195594079565 ()
  • 10195594079567 ()
SMA11OSCTN

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594038069

O B PACK
Cardinal Health 200, LLC
SMA34DLWML
In Commercial Distribution

  • 50195594038067 ()
  • 10195594038069 ()
SMA34DLWML

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

SAFE DENT - 00854014003058

STERLIZATION POUCH B
BGSS Company Inc.
STP-7002-B
In Commercial Distribution

  • 00854014003065 ()
  • 00854014003058 ()
  • 00854014003041 ()


  • Sterilization packaging, single-use
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