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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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12 mm x 21 mm Min arthroscopic cutter
VERICEL CORPORATION
82025
In Commercial Distribution

  • 00860004093046 ()
N/A

  • Bone curette, single-use
18mm x 4cm Cannula assembly
VERICEL CORPORATION
82018
In Commercial Distribution

  • 00860004093039 ()
N/A

  • Arthroscopic access cannula, single-use
15mm x 4cm Cannula Assembly
VERICEL CORPORATION
82017
In Commercial Distribution

  • 00860004093022 ()
N/A

  • Arthroscopic access cannula, single-use
The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)
VERICEL CORPORATION
0
In Commercial Distribution

  • 00860004093015 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD
The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
VERICEL CORPORATION
0
In Commercial Distribution

  • 00860004093008 ()


  • Specimen container mailer, insulated
  • Cell culture medium IVD
No Description
FlexDex Surgical
8ND1L
In Commercial Distribution

  • 00860004002147 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
8ND1M
In Commercial Distribution

  • 00860004002130 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use
No Description
Infinitus Medical Technologies LLC
FPLS-1100
In Commercial Distribution

  • 00860003986899 ()
FPLS-1100

  • Operating table patient positioning set, single-use
No Description
Infinitus Medical Technologies LLC
FPLS-1000-HDP
In Commercial Distribution

  • 00860003986882 ()
FPLS-1000-HDP

  • Operating table patient positioning set, single-use
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