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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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Amplatz Needle Holder With Silicone Inserts
COOK INCORPORATED
G57297
In Commercial Distribution

  • 00827002572973 ()
090000-D

  • Needle guide, single-use
INTRODUCER NEEDLE 100MM PER AMICA-PROBE 16G
H.S. HOSPITAL SERVICE SPA
INTRODUCER NEEDLE
In Commercial Distribution

  • 08033055146081 ()

  • Length: 100 Millimeter
IN 16100N MW

  • Needle guide, single-use
GUILLOTINE NEEDLE 18G X 250MM FOR SOFT TISSUE BIOPSY FOR MAGNUM BARD TM AND PALIUM GUN,WITH COAXIAL
M.D.L. S.R.L.
MGC1825
Not in Commercial Distribution

  • 08058341218907 ()
  • 08032986351533 ()

  • Length: 250 Millimeter
  • Needle Gauge: 18 Gauge
MGC1825

  • Needle guide, single-use
10 CS- GUILLOTINE NEEDLE 14G X 130MM FOR SOFT TISSUE BIOPSY FOR PALIUM AND MAGNUM® BARD GUN, WITH COAXIAL
M.D.L. S.R.L.
MGC1413
Not in Commercial Distribution

  • 08052440100156 ()
  • 08032986351427 ()

  • Needle Gauge: 14 Gauge
  • Length: 130 Millimeter
MGC1413

  • Needle guide, single-use
GUILLOTINE NEEDLE 14Gx100mm FOR SOFT TISSUE, PALIUM AND MAGNUM BARD TM WITH COAXIAL 13Gx75mm
M.D.L. S.R.L.
MGC1410
Not in Commercial Distribution

  • 08032986351410 ()
MGC1410

  • Needle guide, single-use
The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance.
Corbin Clinical Resources, LLC
1
In Commercial Distribution

  • B371P10022 ()
  • B371P10020 ()


  • Needle guide, single-use
The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance.
Corbin Clinical Resources, LLC
1
In Commercial Distribution

  • B371P10010 ()
  • B371P10012 ()
  • B371P10014 ()


  • Needle guide, single-use
No Description
CAMERON-MILLER INC
80-7175
In Commercial Distribution

  • B3708071750 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
No Description
CAMERON-MILLER INC
26-1634
In Commercial Distribution

  • B3702616340 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)
CLEAR GUIDE MEDICAL, INC.
CGSG
In Commercial Distribution

  • B201CGSG0 ()
  • B201CGSG1 ()
  • B201CGSG2 ()
  • B201CGSG3 ()
  • B201CGSG4 ()

  • Needle Gauge: 14 Gauge
CG-SG

  • Needle guide, single-use
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