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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Gelweave Gelatin Impregnated Woven Vascular Prosthesis LUPIAE BRANCHED GRAFT
VASCUTEK LTD
734030CX4RMS
In Commercial Distribution

  • 05037881009032 ()

  • Branch diameter 10/10/8/10 mm
  • Branch length 40/30/30/30 cm
  • Lumen/Inner Diameter: 30 Millimeter
  • Length: 40 Centimeter
734030CX4RMS

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis LUPIAE BRANCHED GRAFT
VASCUTEK LTD
734028CX4RMS
In Commercial Distribution

  • 05037881009025 ()

  • Lumen/Inner Diameter: 28 Millimeter
  • Branch length 40/30/30/30 cm
  • Branch diameter 10/10/8/10 mm
  • Length: 40 Centimeter
734028CX4RMS

  • Synthetic vascular graft
No Description
OCULAR INSTRUMENTS, INC.
OLTCW
In Commercial Distribution

  • 00630238113168 ()


  • Vitrectomy contact lens, reusable
No Description
OCULAR INSTRUMENTS, INC.
OFV-4
In Commercial Distribution

  • 00630238106641 ()


  • Vitrectomy sutureless lens holding ring, reusable
Gelweave Gelatin Impregnated Woven Vascular Prosthesis THORACIC ARCH GRAFT
VASCUTEK LTD
732030CX4
In Commercial Distribution

  • 05037881003207 ()

  • Lumen/Inner Diameter: 30 Millimeter
  • Length: 20 Centimeter
  • Branch length 15/15/30/30 cm
  • Branch diameter 12/8/8/10 mm
732030CX4

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis
VASCUTEK LTD
732026CX4
In Commercial Distribution

  • 05037881003184 ()

  • Branch Diameter 12/8/8/10 mm
  • Lumen/Inner Diameter: 26 Millimeter
732026CX4

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis
VASCUTEK LTD
732024CX4
In Commercial Distribution

  • 05037881003177 ()

  • Branch Diameter 12/8/8/10 mm
  • Lumen/Inner Diameter: 24 Millimeter
732024CX4

  • Synthetic vascular graft
Gelweave Gelatin Impregnated Woven Vascular Prosthesis
VASCUTEK LTD
732022CX4
In Commercial Distribution

  • 05037881003160 ()

  • Branch Diameter 12/8/8/10 mm
  • Lumen/Inner Diameter: 22 Millimeter
732022CX4

  • Synthetic vascular graft
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180416
In Commercial Distribution

  • 00848486000516 ()

  • Side: RIGHT
  • Size: 6
180416

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180415
In Commercial Distribution

  • 00848486000509 ()

  • Size: 5
  • Side: RIGHT
180415

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180414
In Commercial Distribution

  • 00848486000493 ()

  • Size: 4
  • Side: RIGHT
180414

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180413
In Commercial Distribution

  • 00848486000486 ()

  • Size: 3
  • Side: RIGHT
180413

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180412
In Commercial Distribution

  • 00848486000479 ()

  • Side: RIGHT
  • Size: 2
180412

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180408
In Commercial Distribution

  • 00848486000462 ()

  • Size: 8
  • Side: LEFT
180408

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180407
In Commercial Distribution

  • 00848486000455 ()

  • Size: 7
  • Side: LEFT
180407

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180406
In Commercial Distribution

  • 00848486000448 ()

  • Side: LEFT
  • Size: 6
180406

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180405
In Commercial Distribution

  • 00848486000431 ()

  • Size: 5
  • Side: LEFT
180405

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180404
In Commercial Distribution

  • 00848486000424 ()

  • Size: 4
  • Side: LEFT
180404

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180403
In Commercial Distribution

  • 00848486000417 ()

  • Side: LEFT
  • Size: 3
180403

  • Patellofemoral joint prosthesis
MCK Patellofemoral Component
MAKO SURGICAL CORP.
180402
In Commercial Distribution

  • 00848486000400 ()

  • Side: LEFT
  • Size: 2
180402

  • Patellofemoral joint prosthesis
MCK Patella Component
MAKO SURGICAL CORP.
180320-6
In Commercial Distribution

  • 00848486000394 ()

  • Diameter: 41.0 Millimeter
180320-6

  • Polyethylene patella prosthesis
MCK Patella Component
MAKO SURGICAL CORP.
180320-5
In Commercial Distribution

  • 00848486000387 ()

  • Diameter: 38.0 Millimeter
180320-5

  • Polyethylene patella prosthesis
MCK Patella Component
MAKO SURGICAL CORP.
180320-4
In Commercial Distribution

  • 00848486000370 ()

  • Diameter: 35.0 Millimeter
180320-4

  • Polyethylene patella prosthesis
MCK Patella Component
MAKO SURGICAL CORP.
180320-3
In Commercial Distribution

  • 00848486000363 ()

  • Diameter: 32.0 Millimeter
180320-3

  • Polyethylene patella prosthesis
MCK Patella Component
MAKO SURGICAL CORP.
180320-1
In Commercial Distribution

  • 00848486000356 ()

  • Diameter: 26.0 Millimeter
180320-1

  • Polyethylene patella prosthesis
MCK Patella Component
MAKO SURGICAL CORP.
180320-2
In Commercial Distribution

  • 00848486000349 ()

  • Diameter: 29.0 Millimeter
180320-2

  • Polyethylene patella prosthesis
Control Syringe
ADVANCE MEDICAL DESIGNS, INC.
30-CS02
In Commercial Distribution

  • 10848340019422 ()
  • 00848340019425 ()


  • General-purpose syringe, single-use
Control Syringe
ADVANCE MEDICAL DESIGNS, INC.
CS02NS
In Commercial Distribution

  • 10848340009263 ()
  • 00848340009266 ()


  • General-purpose syringe, single-use
Control Syringe
ADVANCE MEDICAL DESIGNS, INC.
CS01NS
In Commercial Distribution

  • 10848340009256 ()
  • 00848340009259 ()


  • General-purpose syringe, single-use
Control Syringe
ADVANCE MEDICAL DESIGNS, INC.
30-CS01
In Commercial Distribution

  • 10848340002073 ()
  • 00848340002076 ()


  • General-purpose syringe, single-use
The Nasal Septal Perforation Sizing Tool (NSPST) is a graded handheld device designed to measure nasal septal perforations. The device is available in oval and round configurations with gradations that coincide with the offered sizes of Blom-Singer® Nasal Septal Perforation Prostheses. The device provides a method for measurement of size and thickness of nasal perforations to aid in selection of the appropriate Blom-Singer® Nasal Septal Perforation Prosthesis. The NSPST is a single use, non-sterile, disposable, invasive, transient duration (<60mins) measuring accessory to the Blom-Singer Nasal Septal Perforation Prosthesis. Each will be packed in a sealed pouch, 5 sealed pouches in one carton box which is sold as 1 unit of SPT 002.
Freudenberg Medical, LLC
SPT 002
In Commercial Distribution

  • 00848253004006 ()
SPT 002

  • Nasal depth gauge, reusable
No Description
Freudenberg Medical, LLC
VP 2212-LEF
In Commercial Distribution

  • 00848253003696 ()


  • Tracheoesophageal speech valve, indwelling
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
No Description
Freudenberg Medical, LLC
VP 2210-LEF
In Commercial Distribution

  • 00848253003689 ()


  • Tracheoesophageal speech valve, indwelling
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
No Description
Freudenberg Medical, LLC
VP 2208-LEF
In Commercial Distribution

  • 00848253003672 ()


  • Tracheoesophageal speech valve, indwelling
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
No Description
Freudenberg Medical, LLC
VP 2206-LEF
In Commercial Distribution

  • 00848253003665 ()


  • Tracheoesophageal speech valve, indwelling
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
Post-Operative Care Kit with 12/55 Tube & EasyFlow HME
Freudenberg Medical, LLC
PK 2107
In Commercial Distribution

  • 00848253003641 ()


  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
Post-Operative Care Kit with 12/55 Tube & ClassicFlow HME
Freudenberg Medical, LLC
PK 2106
In Commercial Distribution

  • 00848253003634 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Voice Prosthesis
Freudenberg Medical, LLC
PK 2105
In Commercial Distribution

  • 00848253003443 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
  • Tracheoesophageal speech valve occluder, non-valved
  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal speech valve irrigation device
  • Airway device cleaning utensil, invasive
  • Tracheoesophageal speech valve, indwelling
Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx
Freudenberg Medical, LLC
PK 2104
In Commercial Distribution

  • 00848253003436 ()


  • Transcervical artificial larynx
  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
Post-Operative Care Kit with 10/55 Tube & EasyFlow HME
Freudenberg Medical, LLC
PK 2103
In Commercial Distribution

  • 00848253003429 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
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