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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Nautilus Monoaxial Assembly CA, Ø5.5 x 35 Long x 5 Lead
Life Spine, Inc.
655-35-5
In Commercial Distribution

  • 00190837057589 ()
655-35-5

  • Bone-screw internal spinal fixation system, non-sterile
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system
BUR TREPHINE 32TL 8ID 8.9OD 14CL CA MRKS 8-10-13 TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948701
In Commercial Distribution

  • 00614950011889 ()

  • Outer Diameter: 8.9 Millimeter
04948701

  • Titanium dental bur
BUR TREPHINE 32TL 7ID 7.9OD 15.8CL CA MRKS 8-10-13-15 TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948502
In Commercial Distribution

  • 00614950011858 ()

  • Outer Diameter: 7.9 Millimeter
04948502

  • Titanium dental bur
BUR TREPHINE 32TL 6ID 6.9OD 15.7CL CA MRKS 8-10-13-15 TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948501
In Commercial Distribution

  • 00614950011841 ()

  • Outer Diameter: 6.9 Millimeter
04948501

  • Titanium dental bur
BUR TREPHINE 32TL 5.25ID 6.1OD 15.5CL CA MRKS 8-10-13-15 TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948401
In Commercial Distribution

  • 00614950011834 ()

  • Outer Diameter: 6.1 Millimeter
04948401

  • Titanium dental bur
BUR TREPHINE 35TL 2ID 2.8OD TI 18.5CL CA MRKS 8-10-13-15-18 INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948001
In Commercial Distribution

  • 00614950011797 ()

  • Outer Diameter: 2.8 Millimeter
04948001

  • Titanium dental bur
BUR TREPHINE 32TL 7ID 7.9OD 15.8CL CA MRKS 8-10-13-15 TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948502
In Commercial Distribution

  • 00614950011704 ()

  • Outer Diameter: 7.9 Millimeter
04948502

  • Titanium dental bur
BUR TREPHINE 32TL 6ID 6.9OD 15.7CL CA MRKS 8-10-13-15 TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948501
In Commercial Distribution

  • 00614950011698 ()

  • Outer Diameter: 6.9 Millimeter
04948501

  • Titanium dental bur
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