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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ampli-energy B 5MC RUP Black
Ws Audiology Usa, Inc.
ampli-energy B 5MC RUP
In Commercial Distribution

  • 05714880118063 ()
10999264

  • Air-conduction hearing aid, behind-the-ear
ampli-energy B 3MC RP Black
Ws Audiology Usa, Inc.
ampli-energy B 3MC RP
In Commercial Distribution

  • 05714880117714 ()
10999210

  • Air-conduction hearing aid, behind-the-ear
ampli-energy B 4MC RP Black
Ws Audiology Usa, Inc.
ampli-energy B 4MC RP
In Commercial Distribution

  • 05714880117646 ()
10999204

  • Air-conduction hearing aid, behind-the-ear
ampli-energy B 5MC RP Black
Ws Audiology Usa, Inc.
ampli-energy B 5MC RP
In Commercial Distribution

  • 05714880117578 ()
10999196

  • Air-conduction hearing aid, behind-the-ear
ampli-energy B 3MC R Black
Ws Audiology Usa, Inc.
ampli-energy B 3MC R
In Commercial Distribution

  • 05714880117431 ()
10999098

  • Air-conduction hearing aid, behind-the-ear
ampli-energy B 4MC R Black
Ws Audiology Usa, Inc.
ampli-energy B 4MC R
In Commercial Distribution

  • 05714880117387 ()
10999092

  • Air-conduction hearing aid, behind-the-ear
ampli-energy B 5MC R Black
Ws Audiology Usa, Inc.
ampli-energy B 5MC R
In Commercial Distribution

  • 05714880117332 ()
10999086

  • Air-conduction hearing aid, behind-the-ear
ampli-energy R 2MC R-D Black
Ws Audiology Usa, Inc.
ampli-energy R 2MC R-D
In Commercial Distribution

  • 05714880117257 ()
10999066

  • Air-conduction hearing aid, receiver-in-canal
CROS Pure Charge&Go AX Black
Ws Audiology Usa, Inc.
CROS Pure Charge&Go AX
In Commercial Distribution

  • 05714880114867 ()
10994013

  • Contralateral hearing unit
Pure Charge&Go AX sDemo Black
Ws Audiology Usa, Inc.
Pure Charge&Go
In Commercial Distribution

  • 05714880113655 ()
10986358

  • Air-conduction hearing aid, receiver-in-canal
M-CORE B-LI-HP 20 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-HP 20
In Commercial Distribution

  • 05714880112146 ()
10996159

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-HP 30 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-HP 30
In Commercial Distribution

  • 05714880112047 ()
10996149

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-HP 40 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-HP 40
In Commercial Distribution

  • 05714880111941 ()
10996139

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-HP 60 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-HP 60
In Commercial Distribution

  • 05714880111842 ()
10996129

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-HP 80 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-HP 80
In Commercial Distribution

  • 05714880111743 ()
10996119

  • Air-conduction hearing aid, receiver-in-canal
M-CORE B-LI-M 20 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-M 20
In Commercial Distribution

  • 05714880110470 ()
10991153

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-M 30 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-M 30
In Commercial Distribution

  • 05714880110371 ()
10991163

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-M 40 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-M 40
In Commercial Distribution

  • 05714880110272 ()
10991173

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-M 60 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-M 60
In Commercial Distribution

  • 05714880110173 ()
10991183

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-M 80 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-M 80
In Commercial Distribution

  • 05714880110074 ()
10991193

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-P 20 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-P 20
In Commercial Distribution

  • 05714880108767 ()
10995508

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-P 30 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-P 30
In Commercial Distribution

  • 05714880108668 ()
10995524

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-P 40 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-P 40
In Commercial Distribution

  • 05714880108569 ()
10995535

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-P 60 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-P 60
In Commercial Distribution

  • 05714880108460 ()
10995550

  • Air-conduction hearing aid, behind-the-ear
M-CORE B-LI-P 80 Black
Ws Audiology Usa, Inc.
M-CORE B-LI-P 80
In Commercial Distribution

  • 05714880108361 ()
10995562

  • Air-conduction hearing aid, behind-the-ear
Motion Charge&Go 3X Black
Ws Audiology Usa, Inc.
Motion Charge&Go 3X
In Commercial Distribution

  • 05714880105780 ()
10970900

  • Air-conduction hearing aid, receiver-in-canal
Motion Charge&Go 2X Black
Ws Audiology Usa, Inc.
Motion Charge&Go 2X
In Commercial Distribution

  • 05714880105759 ()
10970890

  • Air-conduction hearing aid, receiver-in-canal
Motion Charge&Go 1X Black
Ws Audiology Usa, Inc.
Motion Charge&Go 1X
In Commercial Distribution

  • 05714880105582 ()
10970793

  • Air-conduction hearing aid, receiver-in-canal
Motion Charge&Go 7X Black
Ws Audiology Usa, Inc.
Motion Charge&Go 7X
In Commercial Distribution

  • 05714880105568 ()
10970936

  • Air-conduction hearing aid, receiver-in-canal
Motion Charge&Go 5X Black
Ws Audiology Usa, Inc.
Motion Charge&Go 5X
In Commercial Distribution

  • 05714880105469 ()
10970910

  • Air-conduction hearing aid, receiver-in-canal
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
PMB-SSY65-1
In Commercial Distribution

  • 05712821013378 ()
PMB-SSY65-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
PMB-SSY48-1
In Commercial Distribution

  • 05712821013361 ()
PMB-SSY48-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
PMB-BCE60-1
In Commercial Distribution

  • 05712821013354 ()
PMB-BCE60-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
PMB-BCE50-1
In Commercial Distribution

  • 05712821013347 ()
PMB-BCE50-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
PMB-BCE41-1
In Commercial Distribution

  • 05712821013330 ()
PMB-BCE41-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
PMB-BCE34-1
In Commercial Distribution

  • 05712821013323 ()
PMB-BCE34-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-SBX45-1
In Commercial Distribution

  • 05712821013309 ()
CPMB-SBX45-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
PMB-SBX45-1
In Commercial Distribution

  • 05712821012890 ()
PMB-SBX45-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-ZSV57-1
In Commercial Distribution

  • 05712821011985 ()
CPMB-ZSV57-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-ZSV45-1
In Commercial Distribution

  • 05712821011978 ()
CPMB-ZSV45-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-ZSV35-1
In Commercial Distribution

  • 05712821011961 ()
CPMB-ZSV35-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-SSY65-1
In Commercial Distribution

  • 05712821011954 ()
CPMB-SSY65-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-SSY48-1
In Commercial Distribution

  • 05712821011947 ()
CPMB-SSY48-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-SBO41-1
In Commercial Distribution

  • 05712821011930 ()
CPMB-SBO41-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-SBO33-1
In Commercial Distribution

  • 05712821011923 ()
CPMB-SBO33-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-NGM45-1
In Commercial Distribution

  • 05712821011916 ()
CPMB-NGM45-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-NBR60-1
In Commercial Distribution

  • 05712821011909 ()
CPMB-NBR60-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-NBR50-1
In Commercial Distribution

  • 05712821011893 ()
CPMB-NBR50-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-NBR43-1
In Commercial Distribution

  • 05712821011886 ()
CPMB-NBR43-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled 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 either an Elos Medtech approved milling facility or at point of use. The Pre-Milled 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
CPMB-NBR35-1
In Commercial Distribution

  • 05712821011879 ()
CPMB-NBR35-1

  • Dental implant suprastructure, permanent, preformed
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