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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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Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 3 x 1g Sealant Syringe (Opaque White), 10 Dispensing Tips, 1 x 4g Alpha-Etch® 37 Syringe, 10 Dispensing Tips, 20 Disposable Brushes
DENTAL TECHNOLOGIES, INC.
401.0009.002
In Commercial Distribution

  • D73540100090020 ()
401.0009.002

  • Dental pit/fissure sealant
ALUMINUM STORAGE / STERILIZATION CONTAINER W/ PERFORATED LID & BOTTOM, W/ BRACKETS FOR MOUNTING KELLY WICK TUNNELER; 25-1/2"L X 7-3/4"W X 3-1/2"H
ELMED INCORPORATED
55040-40KW
In Commercial Distribution

  • 00842180170049 ()
55040-40KW

  • Instrument transport trolley system
5 MM DIA., 33 CM, INSULATED CUTTING ELECTRODE ACCORDING TO DR. VALLE, WITH CHUCK FOR USE WITH MICRO NEEDLES (150 MICRON # 52005-33 + MICRON # 52005-34) ORDER SEPARETLY.
ELMED INCORPORATED
52205-48
In Commercial Distribution

  • 00842180107120 ()
52205-48

  • Laparoscope system, reusable
HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
Qingdao Hightop Biotech Co., Ltd.
Cassette
In Commercial Distribution

  • 16935091670003 ()
  • 06935091670006 ()
  • 26935091670000 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
GOOD CLEAN LOVE, INC.
2 oz
In Commercial Distribution

  • 30850014621477 ()
  • 00850014621476 ()
900300

  • General-body orifice lubricant, non-sterile
Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
GOOD CLEAN LOVE, INC.
1.0 oz
In Commercial Distribution

  • 00893268000130 ()
  • 30893268000131 ()
900250

  • General-body orifice lubricant, non-sterile
The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ensures high stability and adjustment of the arthrodeses.
Ascension Orthopedics, Inc.
2801106
In Commercial Distribution

  • M26928011061 ()
  • 10381780119296 ()

  • 37 mm L x 1.6 mm W x 6.00 mm H
2801106

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ensures high stability and adjustment of the arthrodeses.
Ascension Orthopedics, Inc.
2801105
In Commercial Distribution

  • M26928011051 ()
  • 10381780119289 ()

  • 37 mm L x 1.6 mm W x 5.00 mm H
2801105

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ensures high stability and adjustment of the arthrodeses.
Ascension Orthopedics, Inc.
2801104
In Commercial Distribution

  • M26928011041 ()
  • 10381780119272 ()

  • 37 mm L x 1.6 mm W x 4.00 mm H
2801104

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ensures high stability and adjustment of the arthrodeses.
Ascension Orthopedics, Inc.
2801103
In Commercial Distribution

  • M26928011031 ()
  • 10381780119265 ()

  • 37 mm L x 1.6 mm W x 3.00 mm H
2801103

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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