SEARCH RESULTS FOR: (*Imitation St. Paul*)(15391 results)

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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 St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
704.08A
In Commercial Distribution

  • B15170408A0 ()
704.08A

  • Cranial orthosis
No Description
Biomet Orthopedics, LLC
35-351564
In Commercial Distribution

  • 00880304359642 ()

  • .062 (D) X 9 (L) SNG/ST
35-351564

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351534
In Commercial Distribution

  • 00880304359581 ()

  • .045 (D) X 9 (L) SNG/ST
35-351534

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351208
In Commercial Distribution

  • 00880304359390 ()

  • .062 (D) X 4 (L) SNG/ST
35-351208

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351578
In Commercial Distribution

  • 00887868101502 ()

  • .062 (D) X 9 (L) SNG/ST
35-351578

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351570
In Commercial Distribution

  • 00887868101496 ()

  • .062 (D) X 4 (L) SNG/ST
35-351570

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351568
In Commercial Distribution

  • 00887868101489 ()

  • .062 (D) X 4 (L) SNG/ST
35-351568

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351566
In Commercial Distribution

  • 00887868101472 ()

  • .062 (D) X 12 (L) SNG/ST
35-351566

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351558
In Commercial Distribution

  • 00887868101458 ()

  • .054 (D) X 4 (L) SNG/ST
35-351558

  • Orthopaedic bone wire
No Description
Biomet Orthopedics, LLC
35-351548
In Commercial Distribution

  • 00887868101441 ()

  • .045 (D) X 9 (L) SNG/ST
35-351548

  • Orthopaedic bone wire
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