Quad Helix 852-551

GUDID 00190746133459

Orthodontic appliance system, adjustable

Primary Device ID	00190746133459
NIH Device Record Key	2ba9f08c-c90c-4d68-9ba7-ac614a8e5082
Commercial Distribution Status	In Commercial Distribution
Brand Name	Quad Helix
Version Model Number	852-551
Catalog Number	852-551
Company DUNS	044668515
Company Name	AMERICAN ORTHODONTICS CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
Serial Number	false
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
GS1	00190746133459 [Primary]

DYJ	RETAINER, SCREW EXPANSION, ORTHODONTIC

Steralize Prior To Use	false
Device Is Sterile	false

00190746133503	QUAD-HELIX PREFORMED SPRINGS CURVED SHEATH LARGE 036 3/PK
00190746133497	QUAD-HELIX PREFORMED SPRINGS CURVED SHEATH MEDIUM 036 3/PK
00190746133480	QUAD-HELIX PREFORMED SPRINGS CURVED SHEATH SMALL 036 3/PK
00190746133473	QUAD-HELIX PRFORMED SPRINGS STRAIGHT SHEATH LARGE 036 3/PKG
00190746133466	QUAD-HELIX PREFORMED SPRINGS STRAIGHT SHEATH MEDIUM 036 3/PKG
00190746133459	QUAD-HELIX PREFORMED SPRINGS STRAIGHT SHEATH SMALL 036 3/PKG

Mark Image Registration \| Serial	Company Trademark Application Date
QUAD HELIX 75413991 2222747 Live/Registered	FUN SPOT OF FLORIDA, INC. 1998-01-05