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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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ELCA™ - M2041172050

ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
117-205
Not in Commercial Distribution

  • M2041172050 ()

  • Outer Diameter: 1.65 Millimeter
117-205

  • Atherectomy laser system beam guide-catheter, coronary

ELCA™ - M2041170160

ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
117-016
Not in Commercial Distribution

  • M2041170160 ()

  • Outer Diameter: 1.75 Millimeter
117-016

  • Atherectomy laser system beam guide-catheter, coronary

ELCA™ - M2041140090

ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
114-009
Not in Commercial Distribution

  • M2041140090 ()

  • Outer Diameter: 1.45 Millimeter
114-009

  • Atherectomy laser system beam guide-catheter, coronary

ELCA™ - M2041100040

ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-004
Not in Commercial Distribution

  • M2041100040 ()

  • Outer Diameter: 0.97 Millimeter
110-004

  • Atherectomy laser system beam guide-catheter, coronary

ELCA™ - M2041100030

ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-003
Not in Commercial Distribution

  • M2041100030 ()

  • Outer Diameter: 0.97 Millimeter
110-003

  • Atherectomy laser system beam guide-catheter, coronary

ELCA™ - M2041100020

ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-002
Not in Commercial Distribution

  • M2041100020 ()

  • Outer Diameter: 0.97 Millimeter
110-002

  • Atherectomy laser system beam guide-catheter, coronary

ELCA™ - M2041100010

ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
110-001
Not in Commercial Distribution

  • M2041100010 ()

  • Outer Diameter: 0.97 Millimeter
110-001

  • Atherectomy laser system beam guide-catheter, coronary

Alpha VI 60mm Transfer Device - M097TDA20600

Alpha VI 60mm Transfer Device for the Novoste Beta-Cath System
BEST VASCULAR, INC.
TDA-2060
In Commercial Distribution

  • M097TDA20600 ()
TDA-2060

  • Manual-afterloading brachytherapy system source transfer device

Alpha VI 30mm Transfer Device - M097TDA20300

Alpha VI 30mm Transfer Device for the Beta-Cath System
BEST VASCULAR, INC.
TDA-2030
In Commercial Distribution

  • M097TDA20300 ()
TDA-2030

  • Manual-afterloading brachytherapy system source transfer device

Patient-Fitted TMJ Reconstructive Prosthesis System - B004YYMMDDNNNNRM0

Right Mandibular Component
TMJ Solutions, Inc.
YYMMDDNNNNRM
In Commercial Distribution

  • B004YYMMDDNNNNRM0 ()


  • Total temporomandibular joint prosthesis
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