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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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The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-18-WNT-PCG
In Commercial Distribution

  • 00689281035392 ()
03539

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Serena-Seat is not to be used in any other way than described above.
Healthcraft Products Inc.
INV-WSAL-18-WNT-ORB
In Commercial Distribution

  • 00689281035415 ()
03541

  • Shower seat, non-powered
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-45
In Commercial Distribution

  • 00855920006683 ()

  • Height: 26.0 Centimeter
  • Length: 10.2 Centimeter
CE017M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-39
In Commercial Distribution

  • 00855920006669 ()

  • Height: 26.0 Centimeter
  • Length: 10.6 Centimeter
CE013M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-48
In Commercial Distribution

  • 00855920006645 ()

  • Height: 18.0 Centimeter
  • Length: 10.1 Centimeter
CE019M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-34
In Commercial Distribution

  • 00855920006607 ()

  • Height: 15.0 Centimeter
  • Length: 20.0 Centimeter
CE0608

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-35
In Commercial Distribution

  • 00855920006584 ()

  • Height: 5.0 Centimeter
  • Length: 20.0 Centimeter
CE0208

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-33
In Commercial Distribution

  • 00855920006560 ()

  • Height: 2.5 Centimeter
  • Length: 7.6 Centimeter
CE0103

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-37
In Commercial Distribution

  • 00855920006690 ()

  • Height: 2.5 Centimeter
  • Length: 10.2 Centimeter
CE0104

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-46
In Commercial Distribution

  • 00855920006676 ()

  • Height: 22.0 Centimeter
  • Length: 8.6 Centimeter
CE017S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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