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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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Raypilot Transmitter Tester is to test the function of the transmitter, which is included in Raypilot Hypocath.
Micropos Medical AB (Publ)
1
In Commercial Distribution

  • 07350007954060 ()
4006

  • Radiation therapy invasive marker lesion localization system
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
The basis is part of the container which product number is 519950ND and that is used for transport and sterilization of the Panta® Nail Removal Kit.
NEWDEAL
519951ND
Not in Commercial Distribution

  • M248519951ND1 ()
  • 10381780042792 ()


  • Device sterilization/disinfection container, reusable
The tray base is part of the container which product number is 339900ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
339910ND
Not in Commercial Distribution

  • M248339910ND1 ()
  • 10381780042693 ()


  • Device sterilization/disinfection container, reusable
The upper basis is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299911ND
Not in Commercial Distribution

  • M248299911ND1 ()
  • 10381780042471 ()


  • Device sterilization/disinfection container, reusable
The screw rack is part of the container which product number is 188202ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
188216ND
Not in Commercial Distribution

  • M248188216ND1 ()
  • 10381780042372 ()


  • Device sterilization/disinfection container, reusable
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
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
HD-15A
In Commercial Distribution

  • 00850035134887 ()


  • Cosmetic red-light phototherapy system, home-use
The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in ten-hole.
Ascension Orthopedics, Inc.
HFP0930310LS
In Commercial Distribution

  • 10381780120834 ()
  • M268HFP0930310LS1 ()

  • 5.450 mm L
HFP0930310LS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in ten-hole.
Ascension Orthopedics, Inc.
HFP0930310RS
In Commercial Distribution

  • 10381780120827 ()
  • M268HFP0930310RS1 ()

  • 5.450 mm L
HFP0930310RS

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Integra Proximal Humeral Fracture Plate System is composed of this left reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in seven-hole.
Ascension Orthopedics, Inc.
HFP0930307LS
In Commercial Distribution

  • 10381780120810 ()
  • M268HFP0930307LS1 ()

  • 4.512 mm L
HFP0930307LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The Integra Proximal Humeral Fracture Plate System is composed of this right reconstruction plate implant. The plate is made from stainless steel. The humeral fracture plate is designed to cover the greater tuberosity and is available in seven-hole.
Ascension Orthopedics, Inc.
HFP0930307RS
In Commercial Distribution

  • 10381780120803 ()
  • M268HFP0930307RS1 ()

  • 4.512 mm L
HFP0930307RS

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