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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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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 Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Laparoscopic or Open Repair of Abdominal Wall Hernia as Trans-fascial sutures, in addition to the tackers. Kumar T-ANCHORS® eliminate the need for grasping and feeding of sutures into a Suture Passer.
NASHVILLE SURGICAL INSTRUMENTS, LLC
TA-008
In Commercial Distribution

  • B361TA0080 ()
  • B361TA0081 ()
TA-008

  • Surgical mesh T fastener
The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free.
NASHVILLE SURGICAL INSTRUMENTS, LLC
CC019
In Commercial Distribution

  • B361CC0190 ()
  • B361CC0191 ()
CC-019

  • Laparoscopic cholangiography injection catheter/needle
Eye Irrigation Device
ESI CORPORATION
KF100
In Commercial Distribution

  • B360KF100 ()
  • B360KF1000 ()
KF100

  • Eye-surface lavage system
ClearScan
ESI CORPORATION
CS200
In Commercial Distribution

  • B360CS2001 ()
  • B360CS2000 ()
CS200

  • Body-orifice ultrasound imaging transducer cover, image-enhancement
Replacement Part
ESI CORPORATION
011B1236
In Commercial Distribution

  • B360011B12361 ()
  • B360011B12360 ()

  • Length: 14 Inch
011B1236

  • Basic intravenous administration set, noninvasive
The Landmark Catheter Introducer Kit is intended to aid in gaining vascular access, placement, and securing the Landmark REBOA Catheter to the patient. The suture in this kit is intended for temporary securement of the catheter clamp to the patient’s skin. The suture and clamp are to be removed immediately after the catheter is withdrawn.
ZIEN MEDICAL TECHNOLOGIES, INC.
LR-KIT
In Commercial Distribution

  • B090LRKIT1 ()
  • B090LRKIT0 ()
LR-KIT

  • Vascular catheter introduction set, nonimplantable
Protect U Guard Silicone Foam Sterile Dressing 10x10cm
PROTECT U GUARD, LLC
P19131
In Commercial Distribution

  • B086291312 ()
  • B086191311 ()
  • B086091310 ()

  • Width: 10 Centimeter
  • Length: 10 Centimeter


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Protect U Guard Non-Woven Dressing 7x9cm Oval Eye
PROTECT U GUARD, LLC
P29124
In Commercial Distribution

  • B0862191242 ()
  • B086191241 ()
  • B086091240 ()

  • Width: 7 Centimeter
  • Length: 9 Centimeter


  • Adhesive bandage
Protect U Guard Non-Woven Dressing 10x35cm
PROTECT U GUARD, LLC
P19123
In Commercial Distribution

  • B086091230 ()
  • B086191231 ()
  • B086291232 ()

  • Width: 10 Centimeter
  • Length: 35 Centimeter


  • Adhesive bandage
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