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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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Affinity™ - 00763000134532

PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20763000134536 ()
  • 00763000134532 ()


  • Cardiopulmonary bypass system centrifugal pump

DABRA 101 Catheter - 00842362100031

Percutaneous Catheter
Catheter Precision, Inc.
101
In Commercial Distribution

  • 00842362100031 ()


  • Atherectomy laser system beam guide-catheter, peripheral

A1c-Cellular - 00844509000945

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.
STRECK, INC.
211130
In Commercial Distribution

  • 00844509000945 ()

  • Total Volume: 2.0 Milliliter
211130

  • Glycated haemoglobin (HbA1c) IVD, control

A1c-Cellular - 00844509000938

A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2.
STRECK, INC.
211124
In Commercial Distribution

  • 00844509000938 ()

  • Total Volume: 2.0 Milliliter
211124

  • Glycated haemoglobin (HbA1c) IVD, control

Pointe Scientific, Inc. - 00811727011336

Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml
POINTE SCIENTIFIC, INC.
G7540-2
In Commercial Distribution

  • 00811727011336 ()
G7540-2

  • Glycated haemoglobin (HbA1c) IVD, control

LifeSPARC - 00814112020807

LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Rapid Depolyment Cannula
CARDIACASSIST, INC.
5820-3631
Not in Commercial Distribution

  • 00814112020807 ()


  • Vascular dilator, single-use
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump
  • Mobile extracorporeal gas exchange system catheter kit

LifeSPARC - 00814112020791

LifeSPARC Blood Pump Kit with 31 Fr ProtekDuo Veno-Venous Cannula
CARDIACASSIST, INC.
5820-3118
Not in Commercial Distribution

  • 00814112020791 ()


  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump

LifeSPARC - 00814112020784

LifeSPARC Blood Pump Kit with 29 Fr ProtekDuo Veno-Venous Cannula
CARDIACASSIST, INC.
5820-2916
Not in Commercial Distribution

  • 00814112020784 ()


  • Vascular dilator, single-use
  • Mobile extracorporeal gas exchange system catheter kit
  • Cardiopulmonary bypass system mounting unit
  • Cardiopulmonary bypass system centrifugal pump

Suction Valve Holder - 04953170438219

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MD-51
Not in Commercial Distribution

  • 04953170438219 ()
N6178001

  • Endoscope working-channel valve, reusable

Biopsy Valve - 04953170438202

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MD-495
In Commercial Distribution

  • 84953170064117 ()
  • 04953170438202 ()
N6177901

  • Endoscope working-channel valve, reusable

Suction Valve - 04953170438196

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MD-493
In Commercial Distribution

  • 04953170438196 ()
N6177801

  • Endoscope working-channel valve, reusable

Biopsy valve - 04953170438165

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MB-358
In Commercial Distribution

  • 84953170063943 ()
  • 04953170438165 ()
N6177501

  • Endoscope working-channel valve, reusable

Biopsy Valve - 04953170438158

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MB-292
In Commercial Distribution

  • 04953170438158 ()
N6177401

  • Endoscope working-channel valve, reusable

Semi-disposable Biopsy Valve - 04953170437977

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-419
In Commercial Distribution

  • 04953170437977 ()
N6175501

  • Endoscope working-channel valve, reusable

Biopsy Valve - 04953170355943

"MAJ-853 Biopsy valves 140-AL5/160-OL5"
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-853
In Commercial Distribution

  • 04953170355943 ()
N5363700

  • Endoscope working-channel valve, single-use

PENTAX - 04961333073016

PENTAX Adjustable Luer Lock Seal OF-B82
HOYA CORPORATION
OF-B82
Not in Commercial Distribution

  • 04961333073016 ()


  • Endoscope working-channel valve, reusable

PENTAX - 04961333134052

Rubber Inlet Seal OF-B190
HOYA CORPORATION
OF-B190
In Commercial Distribution

  • 04961333134052 ()


  • Endoscope working-channel valve, reusable

Vise Grips - 00847538015720

Vise Grips
SYMMETRY MEDICAL INC.
74-483-000
In Commercial Distribution

  • 00847538015720 ()
2709-03-006

  • Surgical flat-nosed pliers

Small Locking Pliers - 00847538008449

Small Locking Pliers
SYMMETRY MEDICAL INC.
74-675-000
In Commercial Distribution

  • 00847538008449 ()
2500-00-785

  • Surgical flat-nosed pliers

Large Locking Pliers - 00847538008432

Large Locking Pliers
SYMMETRY MEDICAL INC.
74-620-000
In Commercial Distribution

  • 00847538008432 ()
2500-00-759

  • Surgical flat-nosed pliers

Needle Nose Pliers - 00847538006049

Needle Nose Pliers
SYMMETRY MEDICAL INC.
74-670-000
In Commercial Distribution

  • 00847538006049 ()
2500-00-777

  • Surgical flat-nosed pliers

FUJIFILM - 04547410079357

This product is used in medical facilityes and attached to our endoscope to prevent air leak or backflow of body fluid from the forceps inlet. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FOV-LL2
In Commercial Distribution

  • 34547410079358 ()
  • 04547410079357 ()
  • 84547410079353 ()


  • Endoscope working-channel valve, single-use

FUJIFILM - 04547410079326

This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow or air. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FOV-DV7
In Commercial Distribution

  • 34547410079327 ()
  • 04547410079326 ()
  • 84547410079322 ()


  • Endoscope working-channel valve, single-use

FUJIFILM - 04547410480993

This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow of air. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-003
In Commercial Distribution

  • 14547410480990 ()
  • 04547410480993 ()


  • Endoscope working-channel valve, single-use

FUJIFILM - 04547410426380

This product is attached to the instrument channel inlet of a FUJIFILM endoscope at medical facilities under the management of physicians. It is intended to insert an endotherapy device, to prevent leak or backflow of air and/or fluids and to enable the suction function of an endoscope. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-002
In Commercial Distribution

  • 24547410426384 ()
  • 04547410426380 ()
  • 84547410426386 ()


  • Endoscope working-channel valve, single-use

FUJIFILM - 04547410391220

This product is attached to the instrument channel inlet of a FUJIFILM endoscope at medical facilities under the management of physicians. It is intended to insert an endotherapy device, to prevent leak or backflow of air and/or fluids and to enable the suction function of an endoscope. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-001
In Commercial Distribution

  • 24547410391224 ()
  • 04547410391220 ()
  • 84547410391226 ()


  • Endoscope working-channel valve, single-use

Biopsy valve - 04953170063947

"MB-358 SEMI-DISPOSABLE BIOPSY VALVE"
OLYMPUS MEDICAL SYSTEMS CORP.
MB-358
In Commercial Distribution

  • 04953170063947 ()
  • 84953170063943 ()
GX0283

  • Endoscope working-channel valve, reusable

emi-Disposable Biopsy Valve(Thin Type) - 04953170063909

"MB-170 DISPOSABLE BIOPSY VALVE 20PIECES"
OLYMPUS MEDICAL SYSTEMS CORP.
MB-170
In Commercial Distribution

  • 04953170063909 ()


  • Endoscope working-channel valve, reusable

Forceps/Irrigation Plug (Isolated Type) - 04953170063114

"MAJ-891 FORCEPS/IRRIGATION PLUG ISOLATED"
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-891
Not in Commercial Distribution

  • 04953170063114 ()


  • Endoscope working-channel valve, reusable

Biopsy Valve - 04953170062209

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-853
In Commercial Distribution

  • 04953170062209 ()
5826400

  • Endoscope working-channel valve, single-use

Medtronic Reusable Instruments - 00643169121669

ROD EX0112015 GRIPPER 5.5/6.0 VICE
MEDTRONIC SOFAMOR DANEK, INC.
EX0112015
In Commercial Distribution

  • 00643169121669 ()


  • Surgical flat-nosed pliers

Medtronic Reusable Instruments - 00643169106024

INTRODUCER EX1111572 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1111572
In Commercial Distribution

  • 00643169106024 ()


  • Surgical flat-nosed pliers

Medtronic Reusable Instruments - 00643169233928

GRIPPER X0712187 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
X0712187
In Commercial Distribution

  • 00643169233928 ()


  • Surgical flat-nosed pliers

Medtronic Reusable Instruments - 00643169295803

DISTRACTOR EX1212013 5.5/6.0 PLIERS
MEDTRONIC SOFAMOR DANEK, INC.
EX1212013
In Commercial Distribution

  • 00643169295803 ()


  • Surgical flat-nosed pliers

IN.PACT™ Admiral™ - 00643169576353

DEB ADM06015013P 06.00 L150 UL1300 US
MEDTRONIC, INC.
ADM06015013P
In Commercial Distribution

  • 00643169576353 ()

  • Length: 150.0 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576346

DEB ADM06015008P 06.00 L150 UL0800 US
MEDTRONIC, INC.
ADM06015008P
In Commercial Distribution

  • 00643169576346 ()

  • Balloon Length 150 MM
  • Balloon Diameter 6 MM


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576339

DEB ADM05015013P 05.00 L150 UL1300 US
MEDTRONIC, INC.
ADM05015013P
In Commercial Distribution

  • 00643169576339 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 150.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576322

DEB ADM05015008P 05.00 L150 UL0800 US
MEDTRONIC, INC.
ADM05015008P
In Commercial Distribution

  • 00643169576322 ()

  • Balloon Length 150 MM
  • Balloon Diameter 5 MM


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576315

DEB ADM04015013P 04.00 L150 UL1300 US
MEDTRONIC, INC.
ADM04015013P
In Commercial Distribution

  • 00643169576315 ()

  • Length: 150.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated

IN.PACT™ Admiral™ - 00643169576308

DEB ADM04015008P 04.00 L150 UL0800 US
MEDTRONIC, INC.
ADM04015008P
In Commercial Distribution

  • 00643169576308 ()

  • Balloon Length 150 MM
  • Balloon Diameter 4 MM


  • Peripheral angioplasty balloon catheter, drug-coated
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