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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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Rectal Split Balloon Catheter - 00627825007054

with Introducer, 4.5F
Laborie Medical Technologies Canada ULC
9021P4471
In Commercial Distribution

  • 10627825007068 ()
  • 00627825007054 ()


  • Urodynamic manometric catheter, non-electronic

Rectal Split Balloon Catheter - 00627825007023

with Introducer, 4.5F
Laborie Medical Technologies Canada ULC
9021P4470
In Commercial Distribution

  • 10627825007037 ()
  • 00627825007023 ()


  • Urodynamic manometric catheter, non-electronic

Medline Industries, Inc. - 10193489395860

ANGIOPLASTY WITH STENT
MEDLINE INDUSTRIES, INC.
DYNJ67333
In Commercial Distribution

  • 40193489395861 ()
  • 10193489395860 ()
DYNJ67333

  • General surgical procedure kit, non-medicated, single-use

Dual Nasal Cannula Paediatric 2.1m Combined O2 Delivery / CO2 Monitoring Filter - 05055788754862

With Female Luer
FLEXICARE MEDICAL LIMITED
032-12-126AU
In Commercial Distribution

  • 05055788754862 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
  • Nasal oxygen cannula, basic

RICHMAR - 00813520013029

Snaps-Black with Pigtail
COMPASS HEALTH BRANDS CORP.
WS3147
In Commercial Distribution

  • 80813520013025 ()
  • 00813520013029 ()


  • Transcutaneous electrical stimulation lead

eCardiostation Software - B147EC0

Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system

PROS Tail - 00816299012736

Wedge with Tail
Hovertech International
PROS-TAIL
In Commercial Distribution

  • 00816299012750 ()
  • 00816299012736 ()
  • 00816299012774 ()
PROS-TAIL

  • Freestanding patient positioner, single-use

Prima - D76845009K0

Base with Anatite
KEYSTONE DENTAL, INC.
45009K
Not in Commercial Distribution

  • D76845009K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45009K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845008K0

Base with Anatite
KEYSTONE DENTAL, INC.
45008K
Not in Commercial Distribution

  • D76845008K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45008K

  • Dental implant suprastructure, permanent, preformed

Prima - D76845007K0

Base with Anatite
KEYSTONE DENTAL, INC.
45007K
Not in Commercial Distribution

  • D76845007K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45007K

  • Dental implant suprastructure, permanent, preformed
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