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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™ - 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

Trivex System - 00840663106578

TRIVEX System Illuminator
Lemaitre Vascular, Inc.
7210351
In Commercial Distribution

  • 00840663106578 ()
7210351

  • Transillumination phlebectomy system illuminator

iovera Smart Tip - 00816287020231

SMART TIP (3X8.5MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2309-5
In Commercial Distribution

  • 00816287020224 ()
  • 00816287020231 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020217

SMART TIP (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2190-5
In Commercial Distribution

  • 00816287020200 ()
  • 00816287020217 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020149

SMART TIP (3X8.5MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0309-5
In Commercial Distribution

  • 00816287020132 ()
  • 00816287020149 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020286

SMART TIP, STIMULATING (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT2190STIM-5
In Commercial Distribution

  • 00816287020279 ()
  • 00816287020286 ()


  • Hand-held cryosurgical system handpiece tip

iovera Smart Tip - 00816287020187

SMART TIP (1X90MM), 5-PACK
Pacira Pharmaceuticals, Inc.
STT0801-5
In Commercial Distribution

  • 00816287020170 ()
  • 00816287020187 ()


  • Hand-held cryosurgical system handpiece tip
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