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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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Turbo-Elite™ - M2044250010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-011
Not in Commercial Distribution

  • M2044250010 ()

  • Outer Diameter: 2.6 Millimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Elite™ - M204423135010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-135-01
Not in Commercial Distribution

  • M204423135010 ()

  • Outer Diameter: 2.3 Millimeter
423-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044230010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-001
Not in Commercial Distribution

  • M2044230010 ()

  • Outer Diameter: 2.3 Millimeter
423-001

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044201590

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
420-159
Not in Commercial Distribution

  • M2044201590 ()

  • Outer Diameter: 2.0 Millimeter
420-159

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044200060

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
420-006
Not in Commercial Distribution

  • M2044200060 ()

  • Outer Diameter: 2.0 Millimeter
420-006

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044171560

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-156
Not in Commercial Distribution

  • M2044171560 ()

  • Outer Diameter: 1.75 Millimeter
417-156

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044171520

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-152
Not in Commercial Distribution

  • M2044171520 ()

  • Outer Diameter: 1.73 Millimeter
417-152

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044141590

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
414-159
Not in Commercial Distribution

  • M2044141590 ()

  • Outer Diameter: 1.45 Millimeter
414-159

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044141510

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
414-151
Not in Commercial Distribution

  • M2044141510 ()

  • Pore Size: 1.40 Millimeter
414-151

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044101540

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
410-154
Not in Commercial Distribution

  • M2044101540 ()

  • Outer Diameter: 0.97 Millimeter
410-154

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044101520

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
410-152
Not in Commercial Distribution

  • M2044101520 ()

  • Outer Diameter: 0.97 Millimeter
410-152

  • Atherectomy laser system beam guide-catheter, peripheral

Affinity™ CP - 20643169433254

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

  • 20643169433254 ()
  • 00643169433250 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433247

PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
Not in Commercial Distribution

  • 20643169433247 ()
  • 00643169433243 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169433230

PUMP BBAP40 AFFINITY CP CENTRIFUGAL BC
MEDTRONIC, INC.
BBAP40
In Commercial Distribution

  • 20643169433230 ()
  • 00643169433236 ()


  • Cardiopulmonary bypass system centrifugal pump

Affinity™ CP - 20643169785780

PUMP CBAP40 AFF CP CENTRIF CC US/CAN 4PK
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20643169785780 ()
  • 00643169785786 ()


  • Cardiopulmonary bypass system centrifugal pump

HUDSON RCI - 04026704588626

ET TUBE, EXCHANGER, ETX, 35 - 41 FR
TELEFLEX INCORPORATED
IPN044923
In Commercial Distribution

  • 24026704588620 ()
  • 04026704588626 ()
  • 44026704588624 ()

  • Length: 1000 Millimeter
  • Sheridan E.T.X. Endobronchial Tube Exchanger
5-24105

  • Endotracheal tube guide, single-use

Affinity™ CP - 00763000301323

ADAPTER AP40AST AFFINITY CP WW 31L
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00763000301323 ()

  • Outer Diameter: 94.0 Millimeter
  • Height: 28.0 Millimeter
  • Weight: 315.0 Gram


  • 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

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors - 18051160302991

No Description
SPECTRUM MEDICAL SRL
CP22V-NG
In Commercial Distribution

  • 18051160302991 ()


  • Cardiopulmonary bypass system centrifugal pump

Disposable tubings with luer lock for air-fluid exchange - 08717872000619

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1250.B
Not in Commercial Distribution

  • 08717872000619 ()
  • 18717872000616 ()
1250.B

  • Surgical irrigation/aspiration tubing set

Disposable tubings complete with filter for air-fluid exchange - 08717872000602

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
1250.ABD
In Commercial Distribution

  • 08717872000602 ()
  • 18717872000609 ()
1250.ABD

  • Surgical irrigation/aspiration tubing set

Disposable EVA Double Irrigation Line with Air Exchange - 08717872020952

No Description
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
8110.DIL01
In Commercial Distribution

  • 08717872020952 ()
  • 18717872020959 ()
8110.DIL01

  • Surgical irrigation/aspiration tubing set

ICY® Intravascular Heat Exchange Catheter Kit (Heparin) - 00849111075107

The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-3893AE
In Commercial Distribution

  • 00849111075107 ()

  • Length: 38 Centimeter
  • Catheter Gauge: 9.3 French
8700-0657-40

  • Intravascular core temperature regulation system catheter

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

Voca - 00781096541676

Spectacle Frame, Size 65-21-127
MCGEE GROUP, INC., THE
VC Kong Slate Black/Smoke Red
In Commercial Distribution

  • 00781096541676 ()
VCKONGSBSROOSND

  • Spectacle frame

N/A - 00721902813849

INSTRUMENT X065061 BENDER
MEDTRONIC SOFAMOR DANEK, INC.
X065061
In Commercial Distribution

  • 00721902813849 ()


  • Surgical flat-nosed pliers

PILLING - 14026704811448

PLIER LG LCK REG. JAW W/EXTRACT HAMMER
TELEFLEX INCORPORATED
IPN022766
In Commercial Distribution

  • 54026704811446 ()
  • 14026704811448 ()
P38158

  • Surgical flat-nosed pliers

Olympus - 14042761062913

Sealing cap, for WA22870A, 5 pcs.
OLYMPUS Winter & Ibe GmbH
WA22880A
Not in Commercial Distribution

  • 14042761062913 ()
  • 04042761062916 ()
WA22880A

  • Endoscope working-channel valve, single-use

Olympus - 14042761062555

sealing cap, 0.7 mm, for WA63817A,, grey, 20 pcs.
OLYMPUS Winter & Ibe GmbH
WA63821A
In Commercial Distribution

  • 14042761062555 ()
  • 04042761062558 ()
WA63821A

  • Endoscope working-channel valve, single-use

Olympus - 14042761001493

No Description
OLYMPUS Winter & Ibe GmbH
A0344
Not in Commercial Distribution

  • 14042761001493 ()
  • 04042761001496 ()
A0344

  • Endoscope working-channel valve, single-use

Olympus - 14042761001417

Sealing cap, for 5 Fr., 3-ply lamella, 10 pieces
OLYMPUS Winter & Ibe GmbH
A0313
In Commercial Distribution

  • 14042761001417 ()
  • 04042761001410 ()
A0313

  • Endoscope working-channel valve, single-use

Olympus - 14042761001363

Sealing cap, 0.1 mm, 6 pieces
OLYMPUS Winter & Ibe GmbH
A0298
In Commercial Distribution

  • 14042761001363 ()
  • 04042761001366 ()
A0298

  • Endoscope working-channel valve, single-use

Olympus - 14042761001202

Sealing cap, kink protection, 0.4 mm, black, 6 pieces
OLYMPUS Winter & Ibe GmbH
A0286
In Commercial Distribution

  • 14042761001202 ()
  • 04042761001205 ()
A0286

  • Endoscope working-channel valve, single-use

Olympus - 14042761001042

Sealing cap, 1.6 mm, 10 pieces
OLYMPUS Winter & Ibe GmbH
A0223
In Commercial Distribution

  • 14042761001042 ()
  • 04042761001045 ()
A0223

  • Endoscope working-channel valve, single-use

Olympus - 14042761001004

Sealing cap, 3.2 mm, 10 pieces
OLYMPUS Winter & Ibe GmbH
A0205
In Commercial Distribution

  • 14042761001004 ()
  • 04042761001007 ()
A0205

  • Endoscope working-channel valve, single-use

Olympus - 14042761000212

Sealing cap, 0.7 mm, 10 pieces
OLYMPUS Winter & Ibe GmbH
00131
In Commercial Distribution

  • 14042761000212 ()
  • 04042761000215 ()
00131

  • Endoscope working-channel valve, single-use

PENTAX - 14961333079343

Rubber Inlet Seal OF-B173
HOYA CORPORATION
OF-B173
Not in Commercial Distribution

  • 04961333079346 ()
  • 14961333079343 ()


  • Endoscope working-channel valve, reusable

SINGLE USE BIOPSY VALVE (Sterile) - 14953170247573

Disposable biopsy valve MAJ-1555
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1555
In Commercial Distribution

  • 14953170247573 ()
  • 04953170247576 ()
  • 54953170247571 ()
N3043000

  • Endoscope working-channel valve, single-use

SINGLE USE BIOPSY VALVE (Sterile) - 14953170154291

SINGLE USE BIOPSY VALVE MAJ-1218
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1218
In Commercial Distribution

  • 14953170154291 ()
  • 04953170154294 ()
  • 54953170154299 ()
N1058800

  • Endoscope working-channel valve, single-use

SINGLE USE BIOPSY VALVE (Sterile) - 14953170152433

SINGLE USE BIOPSY VALVE MAJ-210
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-210
In Commercial Distribution

  • 14953170152433 ()
  • 04953170152436 ()
  • 54953170152431 ()
GL2167

  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06936603225615

No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-F-EO/FTL-BV-O-EO
In Commercial Distribution

  • 06936603225615 ()


  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06936603224397

No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-P
In Commercial Distribution

  • 06936603224397 ()


  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06936603224380

No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-F
In Commercial Distribution

  • 06936603224380 ()


  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06936603222409

No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-O
In Commercial Distribution

  • 06936603222409 ()


  • Endoscope working-channel valve, single-use

Disposable Biopsy Valve - 06936603217146

No Description
Yangzhou Fartley Medical Instrument Technology Co., Ltd
FTL-BV-P-EO
In Commercial Distribution

  • 06936603217146 ()


  • Endoscope working-channel valve, single-use
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