123-Align

GUDID 90860006415429

U Smile Dental LLC

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Primary Device ID	90860006415429
NIH Device Record Key	1cc89e74-f198-4d10-bad1-5ce346848280
Commercial Distribution Status	In Commercial Distribution
Brand Name	123-Align
Version Model Number	LX-A
Company DUNS	081162949
Company Name	U Smile Dental LLC
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	false
Lot Batch	false
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	90860006415429 [Primary]

FDA Product Code

NXC	Aligner, Sequential

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-06-01
Device Publish Date	2021-05-24

On-Brand Devices [123-Align]

90860006415429	LX-A
00860006415488	12021
00860006415495	12021