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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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REFORM CAPS T RING 14.5/12MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate).
Alcon Laboratories, Inc.
8065225705
In Commercial Distribution

  • 00380652257053 ()

  • Outer diameter compressed : 12.0 Millimeter
  • Outer Diameter: 14.5 Millimeter


  • Capsular tension ring
SW APP A90300 RECHAGER APPLICATION
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000275655 ()


  • Multiple active implantable device programmer
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
In Commercial Distribution

  • 00855728005796 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-003
In Commercial Distribution

  • 10810098650295 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
DILON MEDICAL TECHNOLOGIES LTD
SA0590020
In Commercial Distribution

  • 07290012534058 ()


  • Intraoperative tumour margin analysis probe
SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).
SALIX PHARMACEUTICALS, LTD.
1085003
In Commercial Distribution

  • 00365649850035 ()
  • 10365649850032 ()


  • Anal tissue reconstructive material
Intraspinal Catheter Kit A.1 SureStream Catheter;19-gauge;with Guide Wire B.1 Catheter-threading guide C.1 SureStream Connector;titanium D. Anchors 1 each of 4 styles
Medos International Sàrl
70020US
Not in Commercial Distribution

  • 10886704072553 ()
70020US

  • Spinal port/catheter
Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator, 8mm Bladeless Trocar and one pair of Filshie® Clips.
FEMCARE LIMITED
AVM-954
In Commercial Distribution

  • 15055515602371 ()
AVM-954

  • Fallopian tube clip/band
Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CD1311-36Q
In Commercial Distribution

  • 05414734506113 ()

  • Total Volume: 30.2 Milliliter
CD1311-36Q

  • Single-chamber implantable defibrillator
Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CD1311-36
In Commercial Distribution

  • 05414734506106 ()

  • Total Volume: 30.6 Milliliter
CD1311-36

  • Single-chamber implantable defibrillator
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