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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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The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 1A-B
In Commercial Distribution

  • 05712821004826 ()
  • 05712821008510 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 1A-A
In Commercial Distribution

  • 05712821004819 ()
  • 05712821008503 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 13B-A
In Commercial Distribution

  • 05712821010643 ()
  • 05712821010681 ()
IO 13B-A

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 13A-A
In Commercial Distribution

  • 05712821010636 ()
  • 05712821010674 ()
IO 13A-A

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-B
In Commercial Distribution

  • 05712821010629 ()
  • 05712821010667 ()
IO 12A-B

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-A
In Commercial Distribution

  • 05712821010612 ()
  • 05712821010650 ()
IO 12A-A

  • Dental implant suprastructure, temporary, preformed, reusable
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
Ascension Orthopedics, Inc.
BBS096021LRG
In Commercial Distribution

  • M269BBS096021LRG1 ()
  • 10381780121541 ()

  • 08 Large; .825 in L x .186 in dia Screw
BBS-0960-21LRG

  • Reverse shoulder prosthesis body
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
Ascension Orthopedics, Inc.
BBS096021STD
In Commercial Distribution

  • M269BBS096021STD1 ()
  • 10381780121534 ()

  • 08 Standard; .825 in L x .186 in dia Screw
BBS-0960-21STD

  • Reverse shoulder prosthesis body
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
Ascension Orthopedics, Inc.
BBS096021SML
In Commercial Distribution

  • 10381780121527 ()
  • M269BBS096021SML1 ()

  • 08 Small; .825 in L x .186 in dia Screw
BBS-0960-21SML

  • Reverse shoulder prosthesis body
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002512
In Commercial Distribution

  • 10381780120636 ()
  • M268STEM0950025121 ()

  • 3.86 in L x .470 in dia; Size 12
STEM-0950-025-12

  • Coated shoulder humeral stem prosthesis
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