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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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EdgeCore 20 Pack - 00810047644033

Pink gutta percha core thermal obturator
US ENDODONTICS, LLC
EE2520C
In Commercial Distribution

  • 10810047644030 ()
  • 00810047644033 ()
EE2520C

  • Warm-bonded endodontic obturation system obturator

Provox Dilator 20 - 07331791181184

No Description
Atos Medical AB
8343
In Commercial Distribution

  • 07331791181184 ()
8343

  • Tracheoesophageal fistula dilator, reusable

Provox Dilator 20 - 07331791000409

The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE) punctures that shrinks very fast or are too narrow to insert the selected Provox voice prosthesis. The Dilator may also be used to temporarily block or stent the TE puncture.
Atos Medical AB
7123
In Commercial Distribution

  • 07331791000409 ()
7123

  • Tracheoesophageal fistula dilator, reusable

Provox XtraFlange 20 - 07331791006937

Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only.
Atos Medical AB
7276
In Commercial Distribution

  • 07331791006937 ()

  • Voice Prosthesis Compatibility Fits 20 Fr voice prosthesis
7276

  • Tracheoesophageal speech valve, indwelling

Mix2Vial 20/20mm - 07290108240771

No Description
WEST PHARMA. SERVICES IL, . LTD
8074029
In Commercial Distribution

  • 07290108240771 ()


  • Vial/bottle adaptor, hermetic

ALTRUA™ 20 - 00802526499210

Pacemaker
BOSTON SCIENTIFIC CORPORATION
S205
In Commercial Distribution

  • 00802526499210 ()


  • Dual-chamber implantable pacemaker, rate-responsive

ALTRUA™ 20 - 00802526484421

Pacemaker
BOSTON SCIENTIFIC CORPORATION
S208
In Commercial Distribution

  • 00802526484421 ()


  • Dual-chamber implantable pacemaker, rate-responsive

ALTRUA™ 20 - 00802526484384

Pacemaker
BOSTON SCIENTIFIC CORPORATION
S201
In Commercial Distribution

  • 00802526484384 ()


  • Single-chamber implantable pacemaker, rate-responsive

ALTRUA™ 20 - 00802526499128

Pacemaker
BOSTON SCIENTIFIC CORPORATION
S204
In Commercial Distribution

  • 00802526499128 ()


  • Single-chamber implantable pacemaker, rate-responsive

ALTRUA™ 20 - 00802526484391

Pacemaker
BOSTON SCIENTIFIC CORPORATION
S203
In Commercial Distribution

  • 00802526484391 ()


  • Dual-chamber implantable pacemaker, rate-responsive
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