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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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Cystometry Pack - 00627825007351

with Rectal Split Balloon, 6F
Laborie Medical Technologies Canada ULC
9021T1041
In Commercial Distribution

  • 10627825008515 ()
  • 00627825007351 ()


  • Urodynamic manometric catheter, non-electronic

Cystometry Pack - 00627825007269

with Rectal Split balloon, 8F
Laborie Medical Technologies Canada ULC
9021T1011
In Commercial Distribution

  • 10627825007273 ()
  • 00627825007269 ()


  • Urodynamic manometric catheter, non-electronic

2-lumen Catheter Pack - 00627825007238

with Rectal Split Balloon, 8F
Laborie Medical Technologies Canada ULC
9021T1001
In Commercial Distribution

  • 10627825007242 ()
  • 00627825007238 ()


  • Urodynamic manometric catheter, non-electronic

PREIRUS - 04961333243143

ULTRASOUND SYSTEM WITH SONO - DEMO
PENTAX OF AMERICA, INC.
HV-PREIRUS-D
In Commercial Distribution

  • 04961333243143 ()


  • General-purpose ultrasound imaging system

N/A - 04961333244287

ADAPTER FOR 70K WITH FWJ
PENTAX OF AMERICA, INC.
QPC1724
In Commercial Distribution

  • 04961333244287 ()


  • Luminal device flushing tubing set, reusable

N/A - 04961333240807

DISPOSABLE 2500CC LINER WITH SOLIDIFIER
PENTAX OF AMERICA, INC.
67078
In Commercial Distribution

  • 04961333240807 ()

  • Total Volume: 2.5 Liter


  • Surgical fluid/gas irrigator

N/A - 04961333240791

DISPOSABLE 1500CC LINER WITH SOLIDIFIER
PENTAX OF AMERICA, INC.
67077
In Commercial Distribution

  • 04961333240791 ()

  • Total Volume: 1.5 Liter


  • Surgical fluid/gas irrigator

VIDEO COLONOSCOPE - 04961333232321

VIDEO COLONOSCOPE WITH ZOOM (REFURBISHED)
PENTAX OF AMERICA, INC.
EC-3870LZK
Not in Commercial Distribution

  • 04961333232321 ()


  • Flexible video colonoscope, reusable

CARDINAL HEALTH - 10888439612134

MINOR PROCEDURE WITH BASIN PK
Cardinal Health 200, LLC
SBA69MNECI
In Commercial Distribution

  • 50888439612132 ()
  • 10888439612134 ()
SBA69MNECI

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

CARDINAL HEALTH - 10888439612110

MAJOR PROCEDURE WITH BASIN PK
Cardinal Health 200, LLC
SBA69MPECH
In Commercial Distribution

  • 50888439612118 ()
  • 10888439612110 ()
SBA69MPECH

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