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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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First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages in differenet size
In Commercial Distribution

  • 00808829119695 ()


  • Skin-cover adhesive strip, non-antimicrobial
First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
DELTA BRANDS INC.
Bandages in differenet size
In Commercial Distribution

  • 00808829041002 ()


  • Skin-cover adhesive strip, non-antimicrobial
Dorma 500 Auto, India
Respironics, Inc.
Dorma 500 Auto, IN
Not in Commercial Distribution

  • 00606959036857 ()
INDV501

  • Heated respiratory humidifier
  • Home CPAP unit
Custom Tattoo bandage in white or colored dispenser
Scribe Opco, Inc.
Cust Tattoo in Dispenser
In Commercial Distribution

  • 00850013750054 ()


  • Adhesive bandage
Custom White Bandage in White or Colored Dispenser
Scribe Opco, Inc.
Cust White in Dispenser
In Commercial Distribution

  • 00850013750030 ()


  • Adhesive bandage
No Description
PREVEST DENPRO LIMITED
Regular Pack in Box
In Commercial Distribution

  • D96740037B0 ()
40037-2

  • Calcium hydroxide dental cement
No Description
PREVEST DENPRO LIMITED
Regular Pack in Box
In Commercial Distribution

  • D9674003720 ()
40037-2

  • Calcium hydroxide dental cement
No Description
CRAWFORD HEALTHCARE LIMITED
1 x 18 in
In Commercial Distribution

  • 05060077231351 ()
  • 05060077231368 ()
  • 05060077231054 ()

  • Height: 1 Inch
  • Length: 18 Inch
CWL1035

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
No Description
HUGH STEEPER LIMITED
ELECTRODE SEAL IN KIT
In Commercial Distribution

  • 05055348248251 ()
ELSK

  • Myoelectric hand prosthesis
The Rondex CPR Pocket Rescue Mask, Model #9140-PB, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic poly-bag along with the valve. Made In USA
RONDEX PRODUCTS, INCORPORATED
9140-PB (packaged in poly-bag)
Not in Commercial Distribution

  • 06343760091432 ()
9140-PB

  • Cardiopulmonary resuscitation mask, single-use
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