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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Mix2Vial™ 20/20mm w/15µm Large Filter TG S-Spike
WEST PHARMA. SERVICES IL, . LTD
8074044
In Commercial Distribution

  • 27290108240690 ()
  • 07290108240696 ()


  • Medication transfer needle, filtering
M2V 20/20mm w/15mic large filter TG S- Spike
WEST PHARMA. SERVICES IL, . LTD
8074013
In Commercial Distribution

  • 27290108240263 ()
  • 17290108240266 ()
  • 07290108240269 ()


  • Medication transfer needle, filtering
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Regular IOS
Biodenta Swiss AG
CAD-SBOTS45
In Commercial Distribution

  • 07640169731419 ()
CAD-SBOTS45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use
Vial Adapter 20mm FLL TG w/15 mic m Filter - VF
WEST PHARMA. SERVICES IL, . LTD
8072120
Not in Commercial Distribution

  • 27290108240270 ()
  • 17290108240273 ()
  • 37290108240277 ()
  • 07290108240276 ()


  • Vial/bottle adaptor, non-hermetic
No Description
Lonza Verviers
BESP1630Q
In Commercial Distribution

  • 05407010123401 ()


  • Cell culture medium IVD
No Description
Lonza Walkersville, Inc.
04-1154Q
In Commercial Distribution

  • 00840075402619 ()
04-1154Q

  • Ex vivo cell culture medium
No Description
OSANG HEALTHCARE Co., Ltd.
ILM-0001A
In Commercial Distribution

  • 08809115905444 ()


  • Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid
The ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
2Z5061G
In Commercial Distribution

  • 00845533001175 ()
2Z5061G

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
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