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
Lonza Walkersville, Inc.
04-1154Q
In Commercial Distribution

  • 00840075402619 ()
04-1154Q

  • Ex vivo cell culture medium
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
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)
No Description
OSANG HEALTHCARE Co., Ltd.
ILM-0001A
In Commercial Distribution

  • 08809115905444 ()


  • Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid
No Description
MONOBIND, INC.
TG-300
In Commercial Distribution

  • 00816870020198 ()

  • Width: 2 Inch
TG-300

  • Thyroglobulin antibody IVD, control
No Description
Berman Instruments LLC
CKP13
Not in Commercial Distribution

  • 00810060722206 ()


  • Periodontal hoe
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10S1
In Commercial Distribution

  • 00842448114198 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10R1
In Commercial Distribution

  • 00842448114181 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG8R1
In Commercial Distribution

  • 00842448114167 ()


  • Dental implant system
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