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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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Active Pro Monaural R Black-Black
Ws Audiology Usa, Inc.
Active Pro Monaural R
In Commercial Distribution

  • 05714880101898 ()
10991441

  • Air-conduction hearing aid, receiver-in-canal
Active Pro Monaural R Snow White-Rose Gold
Ws Audiology Usa, Inc.
Active Pro Monaural R
In Commercial Distribution

  • 05714880101881 ()
10991442

  • Air-conduction hearing aid, receiver-in-canal
Active Pro Monaural R Black-Silver
Ws Audiology Usa, Inc.
Active Pro Monaural R
In Commercial Distribution

  • 05714880101874 ()
10991443

  • Air-conduction hearing aid, receiver-in-canal
HA AMPLI-ENERGY R MC RDDEMO BLK
Ws Audiology Usa, Inc.
ampli-energy R MC R-D Demo
In Commercial Distribution

  • 05714880101782 ()
10987825

  • Air-conduction hearing aid, receiver-in-canal
ACC. MRIC CHARGE WPC101 TYP A UK,ES,FR,IT,JP,US
Widex A/S
WPC101
In Commercial Distribution

  • 05714879019180 ()
21006771

  • Air-conduction hearing aid, canal
The Device is intended to allow patients or carers to self-administer inject able FDA approved drugs or biologics with a safe, simple and easy injection system. Personal Injector is intended to be used in any setting including the home. Personal Injector is designed for the user - by a user, and here for a lot of emphasis has been put on functionality and injection comfort, appearance. surface, materials, weight, balance, and sound. Personal Injector is an injection system allowing the user to have maximum control and comfort while injecting. Personal Injector differs from commonly known Auto-injector. Until today, marketed Autoinjectors are only for subcutaneous injections. and introduce both the needle and the drug in one motion. The injections are associated with discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site. Personal Injector has a spring-loaded mechanism that only serves to introduce the needle to a pre-determined depth, either subcutaneous or intramuscular. Hereafter the patient can check for air bobbles and vein penetration, and perform a safe traditional manual injection of the drug, by slowly and steady pushing the plunger down. Personal Injector minimises pain and support the patient perform the manual drug introduction, avoiding almost all discomfort. Personal Injector two unique Syringe-I lolders is designed to accommodate FDA approved syringes with fixed and non-fixed needles. Personal Injector is suitable for many injection regimes, including multiple sclerosis patients treatment with interferon beta, cancer treatment, children receiving growth hormone treatment, men injecting local vasodilators to treat erectile dysfunction, and injections of heparin, adrenaline, insulin. apomorphine, and many others medications.
Union Medico ApS
1
In Commercial Distribution

  • 05714472000004 ()


  • Subcutaneous self-injection aid
OTICON OWN SI 1 CIC
Sbo Hearing A/S
284181
In Commercial Distribution

  • 05714464165476 ()


  • Air-conduction hearing aid, canal
OTICON OWN SI 1 IIC
Sbo Hearing A/S
284180
In Commercial Distribution

  • 05714464165469 ()


  • Air-conduction hearing aid, canal
BIRDSONG AOXT9 MNB T R ANBR/MAC
Sbo Hearing A/S
280830
In Commercial Distribution

  • 05714464160686 ()


  • Air-conduction hearing aid, behind-the-ear
BIRDSONG AOXT9 MNB T R SABE/MAC
Sbo Hearing A/S
280829
In Commercial Distribution

  • 05714464160679 ()


  • Air-conduction hearing aid, behind-the-ear
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