St. Louis Band 763.08A

GUDID B15176308A0

Cranial orthosis

Primary Device ID	B15176308A0
NIH Device Record Key	09a4de3f-55d7-41d8-b84b-e74117657bd8
Commercial Distribution Status	In Commercial Distribution
Brand Name	St. Louis Band
Version Model Number	763.08A
Catalog Number	763.08A
Company DUNS	604405373
Company Name	ORTHOMERICA PRODUCTS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B15176308A0 [Primary]

OAN	Orthosis, Cranial, Laser Scan

Steralize Prior To Use	false
Device Is Sterile	false

B15176308PA0	The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr
B15176308A0	The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr
B15170908PA0	The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr
B15170908A0	The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr
B15170408PA0	The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr
B15170408A0	The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to impr