The Signature Smile 9016

GUDID 00816063020240

Sequential Aligner

ALIGN TECHNOLOGY, INC.

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Primary Device ID00816063020240
NIH Device Record Keyfbb036d5-43a7-46f1-860d-f9399a82e9cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Signature Smile
Version Model Number9016
Catalog Number9016
Company DUNS013831768
Company NameALIGN TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816063020240 [Primary]

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-10

Devices Manufactured by ALIGN TECHNOLOGY, INC.

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