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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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No Description
Freudenberg Medical, LLC
IN 2006-LETO
In Commercial Distribution

  • 00813307014416 ()


  • Tracheoesophageal device insertion capsule
  • Tracheoesophageal device introducer
  • Tracheoesophageal fistula spacer/occluder
No Description
Freudenberg Medical, LLC
IN 2004-LETO
In Commercial Distribution

  • 00813307014393 ()


  • Tracheoesophageal fistula spacer/occluder
  • Tracheoesophageal device introducer
  • Tracheoesophageal device insertion capsule
154PCS/054PLS - SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis. 154STY - SINGLE USE castable device: Accessory of conical shape. 047CSD - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with extra soft retention 047CSDSN - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention
RHEIN 83 SRL
OT STRATEGY x DUPLICATION x USA
In Commercial Distribution

098SSSUS

  • Dental implant suprastructure, permanent, preformed
TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.
TELA BIO, INC.
F10068-0408
Not in Commercial Distribution

  • 10856072005132 ()

  • Length: 8 Centimeter
  • Width: 4 Centimeter
F10068-0408

  • Extra-gynaecological surgical mesh, biologic-polymer composite
TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.
TELA BIO, INC.
F10068-1010
Not in Commercial Distribution

  • 10856072005026 ()

  • Length: 10 Centimeter
  • Width: 10 Centimeter
F10068-1010

  • Extra-gynaecological surgical mesh, biologic-polymer composite
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Non-heated, MR850
Carefusion Corporation
RC6Y006095
Not in Commercial Distribution

  • 50885403169760 ()
  • 10885403169762 ()
RC6Y006095

  • Non-heated respiratory humidifier
  • Airway pressure monitor, non-powered
  • Carpal lunate prosthesis
The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by an Elos Medtech approved milling facility. The customized abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
AB-HET451213
In Commercial Distribution

  • 05712821009586 ()
AB-HET451213

  • Dental implant suprastructure, permanent, preformed
The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by an Elos Medtech approved milling facility. The customized abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
AB-ZSV551213O
In Commercial Distribution

  • 05712821003157 ()
AB-ZSV551213O

  • Dental implant suprastructure, permanent, preformed
The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by an Elos Medtech approved milling facility. The customized abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
AB-ZSV451213O
In Commercial Distribution

  • 05712821003133 ()
AB-ZSV451213O

  • Dental implant suprastructure, permanent, preformed
The Abutment Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by an Elos Medtech approved milling facility. The customized abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
AB-ZSV351213O
In Commercial Distribution

  • 05712821003119 ()
AB-ZSV351213O

  • Dental implant suprastructure, permanent, preformed
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