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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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Emmett Hook
REAL STAR SURGICAL INSTRUMENTS
RSSI-130-170
In Commercial Distribution

  • 00860012999606 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
MamaLift Plus is a digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy via software on a mobile application, such as a smartphone or tablet.
Curio Digital Therapeutics Inc.
MamaLift Plus
In Commercial Distribution

  • 00860012970308 ()


  • Mental health/function therapeutic software, screen-viewed
Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution

  • 00860012940608 ()


  • Virtual-display routine exercise software
SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Bath Concept Cosmetics (DongGuan) Co., Ltd.
silicone based lubricant
In Commercial Distribution

  • 00860012900404 ()


  • Sexual lubricant
Maxilla Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759460 ()
GCMAXTI

  • Custom-made orthopaedic/craniofacial surgical guide
Mandible Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759453 ()
GCMANTI

  • Custom-made orthopaedic/craniofacial surgical guide
Fibula cutting guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759446 ()
GCPTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759422 ()
FPCOD

  • Custom-made orthopaedic/craniofacial surgical guide
Interm Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759415 ()
FICOD

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide
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