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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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CAT12 100 New HTORQ shape plus Lightning
PENUMBRA, INC.
LITNG12HTORQ100-A
In Commercial Distribution

  • 00815948022553 ()


  • Thrombectomy suction catheter
  • Suction/irrigation tubing, single-use
*Custom* AMBULNZ HEALTH LLC New Tech Bag
BOUND TREE MEDICAL, LLC
8600-01427
In Commercial Distribution

  • 00812277036008 ()
8600-01427

  • First aid kit, non-medicated, single-use
KIT NEW USSS F.A.T. KIT (7/2002)
BOUND TREE MEDICAL, LLC
NSS2003N
In Commercial Distribution

  • 00815277022804 ()


  • First aid kit, non-medicated, reusable
Surgical kit with new drill stops JDPAD
J DENTAL CARE SRL
Surgical kit with new drill stops JDPAD
In Commercial Distribution

  • 08055510172831 ()
EVPCN:

  • Dental implant system
Soft Tissue Kit in new SCHWERT Wash-Tray
A. Schweickhardt GmbH & Co. KG
1705-120-07E
In Commercial Distribution

  • E896170512007E0 ()
1705-120-07E

  • Periosteal elevator, reusable
5-Lead, New Telemetry, Disp,IEC,Snap,24″
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
EY6509B
In Commercial Distribution

  • 06944904054865 ()
009-004792-00

  • Multiple-patient intensive/general healthcare physiologic monitoring system
3-Lead, New Telemetry, Disp,IEC,Snap,24″
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
EY6313B
In Commercial Distribution

  • 06944904054834 ()
009-004780-00

  • Multiple-patient intensive/general healthcare physiologic monitoring system
OPEN HEART RE OP PACK NEW HAN
Cardinal Health 200, LLC
SCV23ORNLA
In Commercial Distribution

  • 50197106544707 ()
  • 10197106544709 ()
SCV23ORNLA

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
IR ANGIO SET UP PACK NEW HAN
Cardinal Health 200, LLC
SAN23IANLA
In Commercial Distribution

  • 50197106544059 ()
  • 10197106544051 ()
SAN23IANLA

  • Cardiothoracic surgical procedure kit, medicated, single-use
NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD
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