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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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APOZA - 04719883751416

Ultrasonic dental scaling, with Endo.
APOZA ENTERPRISE CO., LTD.
Selector U2
In Commercial Distribution

  • 04719883751416 ()


  • Ultrasonic dental scaling/debridement system

APOZA - 04719883751393

Ultrasonic dental scaling, with Endo.
APOZA ENTERPRISE CO., LTD.
Selector U2 Plus
In Commercial Distribution

  • 04719883751393 ()


  • Ultrasonic dental scaling/debridement system

N/A - 04961333244287

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

  • 04961333244287 ()


  • Luminal device flushing tubing set, reusable

VIDEO COLONOSCOPE - 04961333232321

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

  • 04961333232321 ()


  • Flexible video colonoscope, reusable

2-lumen Cystometry Pack - 00627825007535

with Rectal Split Balloon, 8F
Laborie Medical Technologies Canada ULC
9021T1101
In Commercial Distribution

  • 10627825007549 ()
  • 00627825007535 ()


  • Urodynamic manometric catheter, non-electronic

2-lumen Cystometry Pack - 00627825007504

with Rectal Split Balloon, 6F
Laborie Medical Technologies Canada ULC
9021T1091
In Commercial Distribution

  • 10627825007518 ()
  • 00627825007504 ()


  • Urodynamic manometric catheter, non-electronic

2-lumen Catheter Pack - 00627825007443

with Rectal Split Balloon, 6F
Laborie Medical Technologies Canada ULC
9021T1071
In Commercial Distribution

  • 10627825007457 ()
  • 00627825007443 ()


  • Urodynamic manometric catheter, non-electronic

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
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