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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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Hyflex - D661H82504201

Hyflex CM 04/20 x 25mm File
COLTENE/WHALEDENT INC
H8250420
In Commercial Distribution

  • D661H82504201 ()
  • D661H82504200 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H82106201

Hyflex CM 06/20 x 21mm File
COLTENE/WHALEDENT INC
H8210620
In Commercial Distribution

  • D661H82106201 ()
  • D661H82106200 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H82104201

Hyflex CM 04/20 x 21mm File
COLTENE/WHALEDENT INC
H8210420
In Commercial Distribution

  • D661H82104201 ()
  • D661H82104200 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H083981

Hyflex X-File NT #20 x 25mm File
COLTENE/WHALEDENT INC
H08398
Not in Commercial Distribution

  • D661H083981 ()
  • D661H083980 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H083761

Hyflex X-File NT #20 x 21mm File
COLTENE/WHALEDENT INC
H08376
Not in Commercial Distribution

  • D661H083761 ()
  • D661H083760 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Indy Standalone - 00843210159966

PEEK/Titanium Interbody, 20 °, 42mm x 30mm
Altus Spine, LLC
SL42302020
In Commercial Distribution

  • 00843210159966 ()


  • Polymeric spinal interbody fusion cage

Indy Standalone - 00843210159959

PEEK/Titanium Interbody, 20 °, 42mm x 30mm
Altus Spine, LLC
SL42302019
In Commercial Distribution

  • 00843210159959 ()


  • Polymeric spinal interbody fusion cage

Indy Standalone - 00843210159942

PEEK/Titanium Interbody, 20 °, 42mm x 30mm
Altus Spine, LLC
SL42302018
In Commercial Distribution

  • 00843210159942 ()


  • Polymeric spinal interbody fusion cage

Indy Standalone - 00843210159935

PEEK/Titanium Interbody, 20 °, 42mm x 30mm
Altus Spine, LLC
SL42302017
In Commercial Distribution

  • 00843210159935 ()


  • Polymeric spinal interbody fusion cage

Indy Standalone - 00843210159928

PEEK/Titanium Interbody, 20 °, 42mm x 30mm
Altus Spine, LLC
SL42302016
In Commercial Distribution

  • 00843210159928 ()


  • Polymeric spinal interbody fusion cage
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