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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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Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012159

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 285 cc
Establishment Labs S.A.
ERSD-285Q
In Commercial Distribution

  • 07445161012159 ()
ERSD-285Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012142

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 265 cc
Establishment Labs S.A.
ERSD-265Q
In Commercial Distribution

  • 07445161012142 ()
ERSD-265Q

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161012135

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with Qid 245 cc
Establishment Labs S.A.
ERSD-245Q
In Commercial Distribution

  • 07445161012135 ()
ERSD-245Q

  • Silicone gel-filled breast implant, smooth-surface

N/A - 00613994925985

RECHRGR 97755 RTM PAIN INTELLIS PAPR LIT
MEDTRONIC, INC.
97755
In Commercial Distribution

  • 00613994925985 ()


  • Noninvasive device battery charger

N/A - 00613994925961

SCREENER 97725 PAIN WIRELESS DISP
MEDTRONIC, INC.
97725
In Commercial Distribution

  • 00613994925961 ()


  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

NA - 00613994852731

PRGM 37651 DBS ACTIVA RC W/UPDATES US
MEDTRONIC, INC.
37651
In Commercial Distribution

  • 00613994852731 ()


  • Noninvasive device battery charger

Cordella Calibration Equipment - 00850008997020

The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System. The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include: • Interrogates the Cordella Sensor to verify proper working condition. • Facilitates linking of component serial numbers to patient IDs. • Calibrates the Cordella Sensor to a reference pressure at the time of implantation. • Trains patient on optimal Reader placement post-procedure. • Recalibrates the Cordella Sensor to a reference pressure post-implant. • CalEQ is operated by Endotronix personnel only.
Endotronix, Inc.
100622-00
In Commercial Distribution

  • 00850008997020 ()


  • Implantable pulmonary artery pressure monitoring system

GUARDIAN® MiniLink® CareLink® - 00643169016170

SYSTEM CSS72NSM GRDN CRLINK EN
MEDTRONIC MINIMED, INC.
CSS72NSM
In Commercial Distribution

  • 00643169016170 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Optisure™ - 05414734507202

Defibrillation Lead
ST. JUDE MEDICAL, INC.
LDA220
In Commercial Distribution

  • 05414734507202 ()

  • Length: 65 Centimeter
  • Catheter Gauge: 8.0000 French
LDA220

  • Endocardial defibrillation lead

Optisure™ - 05414734507172

Defibrillation Lead
ST. JUDE MEDICAL, INC.
LDA210
In Commercial Distribution

  • 05414734507172 ()

  • Length: 65 Centimeter
  • Catheter Gauge: 8.0000 French
LDA210

  • Endocardial defibrillation lead
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