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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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Exodus - H965100080

10F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10008
Not in Commercial Distribution

  • H965100081 ()
  • H965100080 ()

  • Outer Diameter: 3.4 Millimeter
  • Catheter Gauge: 10 French
  • Length: 20 Centimeter


  • Closed-wound drain, non-bioabsorbable

Exodus - H965100020

8F x 25cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating
NAVILYST MEDICAL, INC.
10002
Not in Commercial Distribution

  • H965100021 ()
  • H965100020 ()

  • Catheter Gauge: 8 French
  • Outer Diameter: 2.7 Millimeter
  • Length: 25 Centimeter


  • Closed-wound drain, non-bioabsorbable

BioFlo - H954PKM033511S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM033511S
In Commercial Distribution

  • H965PKM033511S1 ()
  • H954PKM033511S0 ()

  • Dual
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter

Wound-Care - G018WC90122411

Gauze Sponge, 2" x 2", 12-PLY, Non-Sterile, (200/PK, 8,000/CS)
Supply Line International Medical, LLC
WC9012241
In Commercial Distribution

  • G018WC90122412 ()
  • G018WC90122411 ()
  • G018WC90122419 ()


  • Non-woven gauze pad, non-sterile

Wound-Care - G018WC90122311

Gauze Sponge, 2" x 2", 8-PLY, Non-Sterile, (200/PK, 5,000/CS)
Supply Line International Medical, LLC
WC9012231
In Commercial Distribution

  • G018WC90122312 ()
  • G018WC90122311 ()
  • G018WC90122319 ()


  • Non-woven gauze pad, non-sterile

Physician's Choice - G018DLH010

Light Handle - Provides a sterile cover over surgical lamp handle.
Supply Line International Medical, LLC
DLH01
In Commercial Distribution

  • G018DLH012 ()
  • G018DLH010 ()


  • Medical equipment handle cover, single-use

BioStamp® nPoint - G012BRCA02

Adhesive with hydrogel
Medidata Solutions, Inc.
BRCA02
In Commercial Distribution

  • G012MC0009 ()
  • G012BRCA02 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder

Techno-Aide - G242MX5N9

EZ Full Wrap Aprons XL - 0.50mm Lead Equivalence-LEAD FREE PROTECTIVE MEDIA
Techno-Aide, Inc.
MX-5N
In Commercial Distribution

  • G242MX5N90 ()
  • G242MX5N9 ()
MX-5N

  • Radiation shielding apron

Techno-Aide - G242MX5L9

EZ Full Wrap Aprons XL - 0.50mm Lead Equivalence-LIGHTWEIGHT LEADED PROTECTIVE MEDIA
Techno-Aide, Inc.
MX-5L
In Commercial Distribution

  • G242MX5L90 ()
  • G242MX5L9 ()
MX-5L

  • Radiation shielding apron

Techno-Aide - G242MX3N9

EZ Full Wrap Aprons XL - 0.35mm Lead Equivalence-LEAD FREE PROTECTIVE MEDIA
Techno-Aide, Inc.
MX-3N
In Commercial Distribution

  • G242MX3N90 ()
  • G242MX3N9 ()
MX-3N

  • Radiation shielding apron
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