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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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SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450070
In Commercial Distribution

  • D010644500701 ()

  • Outer Diameter: 6.5 Centimeter
64450070

  • Dental/surgical polymerization lamp
Freeze Dried Papain is used as a proteolytic enzyme in serological tests. The papain enzyme is derived from Carica papaya. The product configuration is ten (10) vials.
IMMUCOR, INC.
0057292
In Commercial Distribution

  • 10888234000990 ()
0057292

  • Papain immunohaematology reagent IVD
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade. This is a NonFluoride Device
RELIANCE ORTHODONTIC PRODUCTS INC
NFBLSA
In Commercial Distribution

  • D798NFBLSA0 ()
NFBLSA

  • Orthodontic bracket adhesive
BEAR™ mini is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ mini is a smart microcurrent facial toning device.
Foreo AB
PEARL PINK
In Commercial Distribution

  • 07350092139526 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
BEAR™ mini is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ mini is a smart microcurrent facial toning device.
Foreo AB
LAVENDER
In Commercial Distribution

  • 07350092139519 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
This product is phosphate buffer concentrate and is used to buffer saline used in Capture or hemagglutination antibody detection assays. The brand name is pHix. This package configuration is six (6) 200 mL bottles in a box.
IMMUCOR, INC.
0005070
In Commercial Distribution

  • 10888234000501 ()
0005070

  • pH-adjusted buffer solution IVD
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
BA8200
In Commercial Distribution

  • 04715309122938 ()
  • 04715309125243 ()


  • Endometrial biopsy kit
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
M0015
In Commercial Distribution

  • 04715309122051 ()
  • 04715309125021 ()


  • Endometrial biopsy kit
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
M0016
In Commercial Distribution

  • 04715309122068 ()
  • 04715309125014 ()


  • Endometrial biopsy kit
"The ETO Sterilized Preferred Curette is used to obtain a sample from the uterine mucosal lining. The Preferred Curette is a 3mm (O.D.), or 3.6 mm (O.D.) suction curette and is sterile unless the package is opened or damaged. The Preferred Curette is designed for single patient use only. "
PANPAC MEDICAL CORPORATION
M0014
In Commercial Distribution

  • 04715309122044 ()
  • 04715309124987 ()


  • Endometrial biopsy kit
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