Invisalign Impression Tray Medium Lower

GUDID 00816063020400

Medium PVS Lower Tray

Align Technology, Inc.

Dental impression tray, single-use
Primary Device ID00816063020400
NIH Device Record Keyde9bc7c6-c811-48da-bd4e-5702b3ba81e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameInvisalign Impression Tray Medium Lower
Version Model Number2568
Company DUNS013831768
Company NameAlign Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816063020400 [Primary]

FDA Product Code

EHYTray, Impression, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

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