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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 Insightra Medical Freedom Inguinal Hernia Implant (ProFlorâ„¢) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.
INSIGHTRA MEDICAL, INC.
FIHR 40mm
In Commercial Distribution

  • 00013964672381 ()
  • 00850012832072 ()
  • 00850012832089 ()

  • Outer Diameter: 40 Millimeter
FIHR 40mm

  • Extra-gynaecological surgical mesh, composite-polymer
The Insightra Medical Freedom Inguinal Hernia Implant (ProFlorâ„¢) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.
INSIGHTRA MEDICAL, INC.
FIHR 25mmE
In Commercial Distribution

  • 00850012832041 ()
  • 00013964672343 ()
  • 00850012832058 ()

  • Outer Diameter: 25 Millimeter
FIHR 25mmE

  • Extra-gynaecological surgical mesh, composite-polymer
The Insightra Medical Freedom Inguinal Hernia Implant (ProFlorâ„¢) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.
INSIGHTRA MEDICAL, INC.
FIHR 25mm
In Commercial Distribution

  • 00013964672374 ()
  • 00850012832010 ()
  • 00850012832027 ()

  • Outer Diameter: 25 Millimeter
FIHR 25mm

  • Extra-gynaecological surgical mesh, composite-polymer
The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter contains an acorn tip as an aid in seating its distal end at the exocervix.
CROSS BAY MEDICAL, INC.
ETS Plus
In Commercial Distribution

  • 00850012760061 ()
CBPN3003

  • Endometrial biopsy curette
The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter contains an acorn tip as an aid in seating its distal end at the exocervix.
CROSS BAY MEDICAL, INC.
CBPN3001
In Commercial Distribution

  • 00850012760054 ()
  • 10850012760051 ()


  • Endometrial biopsy kit
MR Conditional Disposable EEG Soft Cup Electrode System, 25 lead, soft cups, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-25/S
In Commercial Distribution

  • 00850012681069 ()
  • 00850012681168 ()


  • Analytical scalp electrode, single-use
MR Conditional Disposable EEG Soft Cup electrode system, 23 lead, soft cups, CT compatible
IVES EEG SOLUTIONS, LLC
DCPE-23/S
In Commercial Distribution

  • 00850012681052 ()
  • 10850012681059 ()


  • Analytical scalp electrode, single-use
Hex Torque Wrench (Separate, in Sterile Pack)
Avertix Medical Inc.
2100-001
In Commercial Distribution

  • 00850012625018 ()
  • 10850012625015 ()
2100-001

  • Surgical torque wrench, single-use
IMD AMSG3-E Kit
Avertix Medical Inc.
0212-2100-001#P16
In Commercial Distribution

  • 00850012625001 ()
0212-2100-001#P16

  • Implantable cardiac monitor
Guide Catheter Extension
Seigla Medlcal Inc.
6F LP
In Commercial Distribution

  • 00850012180043 ()

  • Catheter Gauge: 6 French
M3000

  • Vascular guide-catheter extension
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