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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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Short Wire Compatible Biliary Catheter Device
ENDO RX LLC
1
Not in Commercial Distribution

  • 00865014000312 ()
600001-Rhino-SW

  • ERCP catheter, balloon, non-electrical, stone-retrieval
Biliary Stone Removal Device
ENDO RX LLC
1
Not in Commercial Distribution

  • 00865014000305 ()
Model 1

  • ERCP catheter, balloon, non-electrical, stone-retrieval
Tx360EUTM Nasal Applicator
Tian Medical, LLC
Tx360EU
In Commercial Distribution

  • 20864915000302 ()
  • 00864915000339 ()


  • Nasopharyngeal medicine administration kit
Tx360™ Nasal Applicator
Tian Medical, LLC
Tx360
In Commercial Distribution

  • 00864915000308 ()
  • 00864915000315 ()


  • Nasopharyngeal medicine administration kit
Finished Goods, Steerable Introducer, 14 Fr, 80CM - Dexterity
PRIMO MEDICAL GROUP
14 Fr x 80 cm
In Commercial Distribution

  • 10864795000136 ()
  • 00864795000139 ()
60-0007-25

  • Cardiac transseptal access set
FG 9Fr Dexterity Introducer 75cm 2-0 Tip
PRIMO MEDICAL GROUP
9 Fr x 75 cm
In Commercial Distribution

  • 10864795000105 ()
  • 00864795000108 ()
60-0031-20

  • Cardiac transseptal access set
SpaceOAR Systems
BOSTON SCIENTIFIC CORPORATION
SV-2101
In Commercial Distribution

  • 00864661000140 ()

  • Total Volume: 10 Milliliter
SV-2101

  • Radiotherapy protection spacer
TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.
AUGMENIX, INC.
TH-1031
In Commercial Distribution

  • 00864661000133 ()
TH-1031

  • Radiological image marker, implantable
TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.
AUGMENIX, INC.
TH-1011
In Commercial Distribution

  • 00864661000119 ()
TH-1011

  • Radiological image marker, implantable
The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use.
BOSTON SCIENTIFIC CORPORATION
SO-2101
In Commercial Distribution

  • 00864661000102 ()
SO-2101

  • Radiotherapy protection spacer
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