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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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AURADONICS - 00810033834295

SLEEVE .018 ID CLEAR SMOOTH - 10 FT, see www.auradonics.com
AURADONICS INC.
700-618
In Commercial Distribution

  • 00810033834295 ()


  • Orthodontic archwire/bracket ligature

Caterpillar - 00801741175565

Caterpillar Arterial Embolization Device, 0.056 Inch ID Catheter Compatibility
CLEARSTREAM TECHNOLOGIES LIMITED
CTP056030U
Not in Commercial Distribution

  • 00801741175565 ()

  • Marker to Marker Length, 18 Millimeter
CTP056030U

  • Non-neurovascular embolization plug, metallic

Caterpillar - 00801741155314

Caterpillar Arterial Embolization Device, 0.038 Inch ID Catheter Compatibility
CLEARSTREAM TECHNOLOGIES LIMITED
CTP038020U
Not in Commercial Distribution

  • 00801741155314 ()

  • Marker to Marker Length, 17 Millimeters
CTP038020U

  • Non-neurovascular embolization plug, metallic

Blue Sky Bio, LLC - 00810060224120

BIO | Cut Guide Tube 7.17 OD x 6.72 ID
BLUE SKY BIO LLC
TUBE717-672
In Commercial Distribution

  • 00810060224120 ()


  • Surgical torque wrench adaptor

NA - 00887517055644

EMG ET Tube, 7mm ID Long Elec ENT Kit
Nuvasive, Inc.
2010870
In Commercial Distribution

  • 00887517055644 ()


  • Neurophysiologic monitoring system

R3 ACETABULAR - 00885556022313

R3 36MM ID US CERAMIC ACET LINER MM66/68
Smith & Nephew, Inc.
71338966
In Commercial Distribution

  • 00885556022313 ()
71338966

  • Ceramic acetabular liner

TANDEM - 00885556020319

TANDEM BIPOLAR SHELL/XLPE LNR 49MM OD 22MM ID
Smith & Nephew, Inc.
71323049
Not in Commercial Distribution

  • 00885556020319 ()
71323049

  • Bipolar femoral head outer component, hemiarthroplasty

TANDEM - 00885556019962

TANDEM BIPOLAR SHELL/XLPE LNR 44MM OD 22MM ID
Smith & Nephew, Inc.
71323044
Not in Commercial Distribution

  • 00885556019962 ()
71323044

  • Bipolar femoral head outer component, hemiarthroplasty

TANDEM - 00885556019924

TANDEM BIPOLAR SHELL/XLPE LNR 48MM OD 22MM ID
Smith & Nephew, Inc.
71323048
Not in Commercial Distribution

  • 00885556019924 ()
71323048

  • Bipolar femoral head outer component, hemiarthroplasty

TANDEM - 00885556019627

TANDEM BIPOLAR SHELL/XLPE LNR 43MM OD 22MM ID
Smith & Nephew, Inc.
71323043
Not in Commercial Distribution

  • 00885556019627 ()
71323043

  • Bipolar femoral head outer component, hemiarthroplasty
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