a2f2365b-40f5-449c-a0d4-cd01bd70c4e8NewPublished12024-02-022024-01-25In Commercial Distribution00745129303457PrimaryGS122 ChipPad22BR2285-BRR-A189738719SIGVARIS INC1Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. falsetruefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse+1(800)322-7744sigvariscares@sigvaris.com59021Breast implant delivery sleeveA sterile flexible cylinder intended to assist with the delivery of a prefilled breast implant by providing a low-friction shell-tissue interface during implant insertion into a surgically-created breast pocket, without constricting the size of the implant. It is typically made of polyethylene (PE) plastic and is not intended to be used with a lubricant other than saline. The implant is directed through the tube by twisting of the distal end, or by direct manual manipulation. This is a single-use device.falseActive59049General-purpose medical fibre paddingA roll, sheet or preformed shape of synthetic (e.g., polyester, polypropylene) or natural (e.g., cotton) fibre intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.falseActiveKMOBinder, ElasticDevice Size Text, specifyPressure,15-20 mmHgfalsefalse