angel aligner Classic

GUDID 06956748700495

Wuxi EA Medical Instruments Technologies Limited.

Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner
Primary Device ID06956748700495
NIH Device Record Key270e7df4-a3db-4de0-bac8-43c30081d99d
Commercial Distribution StatusIn Commercial Distribution
Brand Nameangel aligner Classic
Version Model NumberEAB II
Company DUNS421315681
Company NameWuxi EA Medical Instruments Technologies Limited.
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106956748700495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

Devices Manufactured by Wuxi EA Medical Instruments Technologies Limited.

06956748701614 - IMPRESS2023-12-14
06956748701270 - angel aligner2023-07-03
06956748700495 - angel aligner Classic2022-07-08
06956748700495 - angel aligner Classic2022-07-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.