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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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ECC Quadrox iD 3/8 - 00607567209985

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 22600
Not in Commercial Distribution

  • 00607567209985 ()
701049440R01

  • Cardiopulmonary bypass system blood tubing set

Adult Pack with Quadrox iD - 00607567205536

BEQ-HMOD 70000-USA Adult Quadrox iD, Better Bladder 3/8, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Gas Filter
DATASCOPE CORP.
BEQ-TOP 13505
Not in Commercial Distribution

  • 00607567205536 ()
701065817

  • Cardiopulmonary bypass system blood tubing set

ECC Quadrox ID Pack RF - 00607567203273

BEQ-HMOD 70000- USA Adult Quadrox ID Blood Transfer Bag 600 ml BEQ-RF32 RotaFLow Gas Filter Temperature Probe
DATASCOPE CORP.
BEQ-TOP 8013
Not in Commercial Distribution

  • 00607567203273 ()
701047962

  • Cardiopulmonary bypass system blood tubing set

ECC Pack with Quadrox iD - 00607567203075

BEQ-HMOD 70000 Softshell venous reser Better Bladder BEQ-RF32 CDI Sat Cell Blood Microfilter System Prebypass Filter
DATASCOPE CORP.
BEQ-TOP 35300
Not in Commercial Distribution

  • 00607567203075 ()
70105506

  • Cardiopulmonary bypass system blood tubing set

ECC Quadrox iD 3/8 - 00607567202986

BEQ-HMOD 70000 Softshell Venous Reser Blood Transfer Bag Flow Probe Connector Blood Microfilter System Prebypass filter Gas Filter
DATASCOPE CORP.
BEQ-TOP 22600
Not in Commercial Distribution

  • 00607567202986 ()
701049440

  • Cardiopulmonary bypass system blood tubing set

PKS DRF 3 - ID 12.2 - 07290019120377

No Description
PATHKEEPER SURGICAL LTD
MAS0007
In Commercial Distribution

  • 17290019120374 ()
  • 07290019120377 ()
  • 07290019120292 ()


  • Optical surgical navigation device tracking system

PKS DRF 4 - ID 7.9 - 07290019120360

No Description
PATHKEEPER SURGICAL LTD
MAS0005
In Commercial Distribution

  • 17290019120367 ()
  • 07290019120360 ()
  • 07290019120254 ()


  • Optical surgical navigation device tracking system

PKS DRF 2 - ID 5.9 - 07290019120353

No Description
PATHKEEPER SURGICAL LTD
MAS0003
In Commercial Distribution

  • 17290019120350 ()
  • 07290019120353 ()
  • 07290019120216 ()


  • Optical surgical navigation device tracking system

LUMINELLE DTx Hysteroscopy System - 00853277008046

Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
UVISION 360, INC.
LumDTX-A
In Commercial Distribution

  • 00853277008046 ()
20030

  • Flexible video cystoscope, reusable
  • Endoscope sheath, single-use
  • Flexible fibreoptic hysteroscope

STERIZONE® VP4 Test Pack Kit - 00690455440201

Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor
TSO3 Inc
44020
In Commercial Distribution

  • 00690455440201 ()
44020

  • Biological sterilization indicator
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