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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TriMark for Eviva
Hologic, Inc.
TRIMARK-EVIVA-10
In Commercial Distribution

  • 05420045503550 ()
  • 15420045503557 ()
TRIMARK-EVIVA-10

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-2S-36-12
Not in Commercial Distribution

  • 05420045503482 ()
SMARK-ATEC-2S-36-12

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-36-12
In Commercial Distribution

  • 05420045503475 ()
  • 15420045503472 ()
SMARK-ATEC-36-12

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-2S-36-09
In Commercial Distribution

  • 05420045503468 ()
  • 15420045503465 ()
SMARK-ATEC-2S-36-09

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-36-09
In Commercial Distribution

  • 05420045503451 ()
  • 15420045503458 ()
SMARK-ATEC-36-09

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-2S-13-12
In Commercial Distribution

  • 05420045503444 ()
  • 15420045503441 ()
SMARK-ATEC-2S-13-12

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-13-12
In Commercial Distribution

  • 05420045503437 ()
  • 15420045503434 ()
SMARK-ATEC-13-12

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-2S-13-09
In Commercial Distribution

  • 05420045503420 ()
  • 15420045503427 ()
SMARK-ATEC-2S-13-09

  • Radiological image marker, implantable
SecurMark for Atec
Hologic, Inc.
SMARK-ATEC-13-09
In Commercial Distribution

  • 05420045503413 ()
  • 15420045503410 ()
SMARK-ATEC-13-09

  • Radiological image marker, implantable
SecurMark for Celero
Hologic, Inc.
SMARK-CELERO-2S
In Commercial Distribution

  • 05420045503406 ()
  • 15420045503403 ()
SMARK-CELERO-2S

  • Radiological image marker, implantable
SecurMark for Celero
Hologic, Inc.
SMARK-CELERO
In Commercial Distribution

  • 05420045503390 ()
  • 15420045503397 ()
SMARK-CELERO

  • Radiological image marker, implantable
CeleroMark biopsy site marker
Hologic, Inc.
CELEROMARK-2S
In Commercial Distribution

  • 05420045503383 ()
  • 15420045503380 ()
CELEROMARK-2S

  • Radiological image marker, implantable
CeleroMark Biopsy Site Identification System
Hologic, Inc.
CELEROMARK
In Commercial Distribution

  • 05420045503376 ()
  • 15420045503373 ()
CELEROMARK

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARKTD-2S-36-12
In Commercial Distribution

  • 05420045503369 ()
  • 15420045503366 ()
TRIMARKTD-2S-36-12

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARKTD-2S-36-09
In Commercial Distribution

  • 05420045503352 ()
  • 15420045503359 ()
TRIMARKTD-2S-36-09

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARKTD-2S-13-MR
In Commercial Distribution

  • 05420045503345 ()
  • 15420045503342 ()
TRIMARKTD-2S-13-MR

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARKTD-2S-13-12
In Commercial Distribution

  • 05420045503338 ()
  • 15420045503335 ()
TRIMARKTD-2S-13-12

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARKTD-2S-13-09
In Commercial Distribution

  • 05420045503321 ()
  • 15420045503328 ()
TRIMARKTD-2S-13-09

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARK TD 3612
In Commercial Distribution

  • 05420045503314 ()
  • 15420045503311 ()
TRIMARK TD 3612

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARK TD 3609
In Commercial Distribution

  • 05420045503307 ()
  • 15420045503304 ()
TRIMARK TD 3609

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARK TD 13MR
In Commercial Distribution

  • 05420045503291 ()
  • 15420045503298 ()
TRIMARK TD 13MR

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARK TD 1312
In Commercial Distribution

  • 05420045503284 ()
  • 15420045503281 ()
TRIMARK TD 1312

  • Radiological image marker, implantable
TriMark TrapDoor (TD)
Hologic, Inc.
TRIMARK TD 1309
In Commercial Distribution

  • 05420045503277 ()
  • 15420045503274 ()
TRIMARK TD 1309

  • Radiological image marker, implantable
12G INTRODUCER FOR USE WITH SUROS CELERO-12 BIOPSY DEVICE
Hologic, Inc.
CELERO INTRO-12
In Commercial Distribution

  • 05420045503222 ()
  • 15420045503229 ()
CELERO INTRO-12

  • Side-notch biopsy gun handpiece/needle
9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-20MR HANDPIECE
Hologic, Inc.
ILS 0914-20
In Commercial Distribution

  • 05420045503208 ()
  • 15420045503205 ()
ILS 0914-20

  • Radiological image marker, implantable
9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-12MR HANDPIECE
Hologic, Inc.
ILS 0914-12
In Commercial Distribution

  • 05420045503192 ()
  • 15420045503199 ()
ILS 0914-12

  • Radiological image marker, implantable
REMOTE TISSUE FILTER ADAPTER
Hologic, Inc.
ATEC RTFA
In Commercial Distribution

  • 05420045503178 ()
  • 15420045503175 ()
ATEC RTFA

  • Mammographic stereotactic biopsy system
TISSUE FILTER
Hologic, Inc.
ATEC TF-1
In Commercial Distribution

  • 05420045503161 ()
  • 15420045503168 ()
ATEC TF-1

  • General tissue specimen container IVD, fixative/saline
ANGLED NEEDLE GUIDE FOR THE AURORA MRI SYSTEM
Hologic, Inc.
ATEC_NG09-A2
In Commercial Distribution

  • 05420045503154 ()
  • 15420045503151 ()
ATEC_NG09-A2

  • Side-notch biopsy gun handpiece/needle
AURORA NEEDLE GUIDE
Hologic, Inc.
ATEC NG09-A1
Not in Commercial Distribution

  • 05420045503147 ()
  • 15420045503144 ()
ATEC NG09-A1

  • Needle guide, single-use
12G NEEDLE GUIDE FOR FISCHER SYSTEM
Hologic, Inc.
ATEC NG12-FISCH
In Commercial Distribution

  • 05420045503130 ()
  • 15420045503137 ()
ATEC NG12-FISCH

  • Needle guide, single-use
12G NEEDLE GUIDE FOR LORAD SYSTEM
Hologic, Inc.
ATEC NG12-LORAD
In Commercial Distribution

  • 05420045503123 ()
  • 15420045503120 ()
ATEC NG12-LORAD

  • Needle guide, single-use
9G NEEDLE GUIDE FOR FISCHER SYSTEM
Hologic, Inc.
ATEC NG09-FISCH
In Commercial Distribution

  • 05420045503116 ()
  • 15420045503113 ()
ATEC NG09-FISCH

  • Needle guide, single-use
9G NEEDLE GUIDE FOR LORAD SYSTEM
Hologic, Inc.
ATEC NG09-LORAD
In Commercial Distribution

  • 05420045503109 ()
  • 15420045503106 ()
ATEC NG09-LORAD

  • Needle guide, single-use
Brain, Head and Neck Interface for MammoRx Breast Board (2 pcs.)
Orfit Industries NV
39320
In Commercial Distribution

  • 05420028799147 ()


  • Radiological whole-body positioner
HP PRO Solution Cranial Back Stop
Orfit Industries NV
25000/6
In Commercial Distribution

  • 05420028798980 ()


  • Radiological whole-body positioner
HP PRO Extension Base Plate with Pin Interface Adult
Orfit Industries NV
25000/1
In Commercial Distribution

  • 05420028798935 ()


  • Radiological whole-body positioner
2pt Chin Mask in Efficast 2.0 mm MAXI
Orfit Industries NV
33776/2MA
In Commercial Distribution

  • 05420028796597 ()


  • Head/neck procedure positioner
Head, Neck, Shoulders Mask
Orfit Industries NV
60001/EFF2MA
In Commercial Distribution

  • 05420028795668 ()


  • Head/neck procedure positioner
AIO Indexable Knee Frame Long
Orfit Industries NV
29055
In Commercial Distribution

  • 05420028795538 ()


  • Radiological whole-body positioner
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