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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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Identification Sheet Tape, White/Lavender stripes, contains different size adhesive strips
Batrik Medical Manufacturing Inc
T-850-4-11
In Commercial Distribution

  • 00690521003514 ()
T-850-4-11

  • Auditory brainstem implant system
Edwards EVOQUE Tricuspid Delivery System
Edwards Lifesciences LLC
9850TDSUS
In Commercial Distribution

  • 00690103217520 ()
9850TDSUS

  • Tricuspid transcatheter heart valve bioprosthesis
PASCAL PRECISION SYSTEM - GUIDE SHEATH
Edwards Lifesciences LLC
20000GSA
In Commercial Distribution

  • 00690103216967 ()
20000GSA

  • Heart valve clip
PASCAL PRECISION SYSTEM – PASCAL ACE IMPLANT SYSTEM
Edwards Lifesciences LLC
20000ISM
In Commercial Distribution

  • 00690103216950 ()
20000ISMA

  • Heart valve clip
PASCAL PRECISION SYSTEM – IMPLANT SYSTEM
Edwards Lifesciences LLC
20000IS
In Commercial Distribution

  • 00690103216943 ()
20000ISA

  • Heart valve clip
SAPIEN 3 PULMONIC DELIVERY SYSTEM - 29MM (US)
Edwards Lifesciences LLC
9630PL29A
In Commercial Distribution

  • 00690103210873 ()

  • Balloon Diameter: 29.0000 Millimeter
9630PL29A

  • Pulmonary transcatheter heart valve bioprosthesis
ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM
Edwards Lifesciences LLC
29AP4045
In Commercial Distribution

  • 00690103210866 ()
29AP4045A

  • Pulmonary transcatheter heart valve bioprosthesis
Transfer Impression Coping for Ø3.25 SD Implant
SOUTHERN IMPLANTS (PTY) LTD
CSD4
In Commercial Distribution

  • 06009544002857 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Transfer Impression Coping for Ø6.0 Compact Conical, Long
SOUTHERN IMPLANTS (PTY) LTD
CMCW2L
In Commercial Distribution

  • 06009544002789 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Transfer Impression Coping for Ø6.0 Compact Conical
SOUTHERN IMPLANTS (PTY) LTD
CMCW2
In Commercial Distribution

  • 06009544002772 ()


  • Dental implant suprastructure, temporary, preformed, single-use
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