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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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POLARIS™ 5.5 SPINAL SYSTEM - 00880304919495

No Description
BIOMET SPINE LLC
2000-5310
In Commercial Distribution

  • 00880304919495 ()

  • 105MM CP TI CURVED ROD WITH HEX
2000-5310

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919488

No Description
BIOMET SPINE LLC
2000-5311
In Commercial Distribution

  • 00880304919488 ()

  • 110MM CP TI CURVED ROD WITH HEX
2000-5311

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919471

No Description
BIOMET SPINE LLC
2000-5312
In Commercial Distribution

  • 00880304919471 ()

  • 115MM CP TI CURVED ROD WITH HEX
2000-5312

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919464

No Description
BIOMET SPINE LLC
2000-5313
In Commercial Distribution

  • 00880304919464 ()

  • 120MM CP TI CURVED ROD WITH HEX
2000-5313

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919457

No Description
BIOMET SPINE LLC
2000-5314
In Commercial Distribution

  • 00880304919457 ()

  • 125MM CP TI CURVED ROD WITH HEX
2000-5314

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919440

No Description
BIOMET SPINE LLC
2000-5315
In Commercial Distribution

  • 00880304919440 ()

  • 130MM CP TI CURVED ROD WITH HEX
2000-5315

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919266

No Description
BIOMET SPINE LLC
2000-5410
In Commercial Distribution

  • 00880304919266 ()

  • 105MM TI ALLOY CURVED ROD WITH HEX
2000-5410

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919259

No Description
BIOMET SPINE LLC
2000-5411
In Commercial Distribution

  • 00880304919259 ()

  • 110MM TI ALLOY CURVED ROD WITH HEX
2000-5411

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919242

No Description
BIOMET SPINE LLC
2000-5412
In Commercial Distribution

  • 00880304919242 ()

  • 115MM TI ALLOY CURVED ROD WITH HEX
2000-5412

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919235

No Description
BIOMET SPINE LLC
2000-5413
In Commercial Distribution

  • 00880304919235 ()

  • 120MM TI ALLOY CURVED ROD WITH HEX
2000-5413

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919228

No Description
BIOMET SPINE LLC
2000-5414
In Commercial Distribution

  • 00880304919228 ()

  • 125MM TI ALLOY CURVED ROD WITH HEX
2000-5414

  • Bone-screw internal spinal fixation system, non-sterile

POLARIS™ 5.5 SPINAL SYSTEM - 00880304919211

No Description
BIOMET SPINE LLC
2000-5415
In Commercial Distribution

  • 00880304919211 ()

  • 130MM TI ALLOY CURVED ROD WITH HEX
2000-5415

  • Bone-screw internal spinal fixation system, non-sterile

PleuraFlow® System - 00856449006017

PF-24 PleuraFlow® System
Clearflow, Inc.
PF-24
Not in Commercial Distribution

  • 20856449006011 ()
  • 00856449006017 ()
  • 10856449006014 ()

  • Catheter Gauge: 24 French


  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter

PleuraFlow® System - 00856449006000

PF-20 PleuraFlow® System
Clearflow, Inc.
PF-20
Not in Commercial Distribution

  • 00856449006000 ()
  • 10856449006007 ()
  • 20856449006004 ()

  • Catheter Gauge: 20 French


  • Pleural catheter
  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial

PleuraFlow® System - 00856449006031

PF-32 PleuraFlow® System
Clearflow, Inc.
PF-32
Not in Commercial Distribution

  • 00856449006031 ()
  • 10856449006038 ()
  • 20856449006035 ()

  • Catheter Gauge: 32 French


  • Closed-wound drain, non-bioabsorbable
  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter

PleuraFlow® System - 00856449006024

PF-28 PleuraFlow® System
Clearflow, Inc.
PF-28
Not in Commercial Distribution

  • 10856449006021 ()
  • 00856449006024 ()
  • 20856449006028 ()

  • Catheter Gauge: 28 French


  • Closed-wound drain, non-bioabsorbable
  • Pleural catheter
  • Mediastinal drainage catheter, non-antimicrobial

Guidewire Extension - 00816349011283

No Description
Lake Region Medical
LR1BN042V
In Commercial Distribution

  • 10816349011280 ()
  • 00816349011283 ()

  • Outer Diameter: 0.014 Inch
  • Length: 145 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use

Triumph - 00816349011276

No Description
Lake Region Medical
LR1BN025V
In Commercial Distribution

  • 00816349011276 ()
  • 10816349011273 ()

  • Outer Diameter: 0.014 Inch
  • Length: 185 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use

Triumph - 00816349011269

No Description
Lake Region Medical
LR1BN023V
In Commercial Distribution

  • 10816349011266 ()
  • 00816349011269 ()

  • Outer Diameter: 0.014 Inch
  • Length: 185 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use

Adult Expandable Circuit 96" Y-Piece with Luer Elbow Bacterial Viral Filter with - 05055788747819

No Description
FLEXICARE MEDICAL LIMITED
038-01-616U
In Commercial Distribution

  • 05055788747819 ()


  • Anaesthesia breathing circuit, single-use
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