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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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NA - 07613327291827

Hyper Small Angled Handpiece without Tip, 25 kHz
STRYKER MEDTECH K.K.
5450806000
In Commercial Distribution

  • 07613327291827 ()
5450-806-000

  • Soft-tissue ultrasonic surgical system handpiece, reusable

NA - 07613327291803

Small Long Angled Handpiece without Tip, 34 kHz
STRYKER MEDTECH K.K.
5450804000
In Commercial Distribution

  • 07613327291803 ()
5450-804-000

  • Soft-tissue ultrasonic surgical system handpiece, reusable

Hyper LT - 07613327289893

Angled Hard Tissue Curette Handpiece without Tip, 25 kHz
STRYKER MEDTECH K.K.
5450814000
In Commercial Distribution

  • 07613327289893 ()
5450-814-000

  • Soft-tissue ultrasonic surgical system handpiece, reusable

Straumann PrefGel - 07630031730053

Straumann® PrefGel®, 5 x 0.6 ml (24% EDTA)
Institut Straumann AG
PrefGel
In Commercial Distribution

  • 07630031730053 ()

  • Total Volume: 0.6 Milliliter
075.203W

  • Dental root surface conditioner

Sonopet iQ - 07613327364675

Ultrasonic Aspirator Console
STRYKER CORPORATION
5500050000
In Commercial Distribution

  • 07613327364675 ()
5500-050-000

  • Ultrasonic surgical system generator

primaLOK FF - 00813210022027

Threaded Implant Holder Shaft - Cannulated
Wenzel Spine, Inc.
800-1212
In Commercial Distribution

  • 00813210022027 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

primaLOK FF - 00813210022003

Removal Driver
Wenzel Spine, Inc.
800-1203
In Commercial Distribution

  • 00813210022003 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

primaLOK FF - 00813210022034

Threaded Implant Holder Shaft - Solid
Wenzel Spine, Inc.
800-1213
In Commercial Distribution

  • 00813210022034 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

primaLOK FF - 00813210022010

Implant Driver
Wenzel Spine, Inc.
800-1211
In Commercial Distribution

  • 00813210022010 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

DRB SSP Kit - 07611969953288

Kit for 24 determinations of HLA-DRB alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826215
Not in Commercial Distribution

  • 07611969953288 ()
826215

  • HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
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