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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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Phasor Drill 6.35-mm diameter, ~70-mm length, with Drill Stop Extension (Tapered) + Kit (version A) with stapler
PHASOR HEALTH LLC
PH-635-70-DT + PH-K-AS
In Commercial Distribution

  • B775PH63570DTPHKAS0 ()
PH-635-70-DT + PH-K-AS

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Phasor Drill 6.35-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (version A1) with stapler
PHASOR HEALTH LLC
PH-635-70-D + PH-K-A1S
In Commercial Distribution

  • B775PH63570DPHKA1S0 ()
PH-635-70-D + PH-K-A1S

  • Craniotomy power tool system, battery-powered, single-use
  • Neurosurgical procedure kit, medicated
Adaptor for easy use with any threaded I/ A Aspirating tip with Silicone sleeve system , Titanium
Crestpoint Management Limited
PH8517T
In Commercial Distribution

  • G412PH8517T0 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
MICTEC HF FLAT ELECTRODE WITH LATERAL SLOTS AND CENTRAL HOLE CURVED WITH CONNECTION TO SUCTION-IRRIGATION VALVES
SONTEC INSTRUMENTS, INC.
20947-11-002
In Commercial Distribution


  • 7mm 30° Tip
  • Length: 300 Millimeter
  • 10mm Valve Connection


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
BioFlo Dual Port with Endexo Technology - Plastic Port with Filled Suture Holes and 8F Polyurethane Catheter
Angiodynamics, Inc.
H965440280
In Commercial Distribution


  • Outer Diameter: 2.6 Millimeter
  • Length: 63 Centimeter
  • Catheter Gauge: 8 French
  • Dual Lumen
44028

  • Vascular port/catheter
BioFlo Dual Port with Endexo Technology - Plastic Port with Non-Filled Suture Holes and 8F Polyurethane Catheter
Angiodynamics, Inc.
H965440270
In Commercial Distribution


  • Length: 63 Centimeter
  • Dual Lumen
  • Catheter Gauge: 8 French
  • Outer Diameter: 2.6 Millimeter
44027

  • Vascular port/catheter
BioFlo Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter with ENDEXO Technology
Angiodynamics, Inc.
H965440140
In Commercial Distribution


  • Lumen/Inner Diameter: 1.6 Millimeter
  • Length: 63 Centimeter
  • Outer Diameter: 2.6 Millimeter
  • Catheter Gauge: 8 French
44014

  • Vascular port/catheter
BioFlo Plastic Port with Filled Suture Holes and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
Angiodynamics, Inc.
H965440120
In Commercial Distribution


  • Outer Diameter: 2.1 Millimeter
  • Lumen/Inner Diameter: 1.3 Millimeter
  • Length: 63 Centimeter
  • Catheter Gauge: 6 French
44012

  • Vascular port/catheter
Silicone Silo Bag with Wire Ring Sizer Ring For Use with the SSP Silicone Silo Bag
SPECIALTY SURGICAL PRODUCTS INC
SSB-SR-10
In Commercial Distribution

  • M746SSBSR100 ()

  • Width: 10.0 Centimeter
SSB-SR-10

  • Negative-pressure wound therapy open-abdomen dressing
Silicone Silo Bag with Wire Ring Sizer Ring For Use with the SSP Silicone Silo Bag
SPECIALTY SURGICAL PRODUCTS INC
SSB-SR-09
In Commercial Distribution

  • M746SSBSR090 ()

  • Width: 9.0 Centimeter
SSB-SR-09

  • Negative-pressure wound therapy open-abdomen dressing
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