GUDID 00817573024179

MODULES-SAFETY 600g BLUE 10/PK

LANCER ORTHODONTICS, INC.

Orthodontic extraoral headgear
Primary Device ID00817573024179
NIH Device Record Key0c581785-7b85-40a5-b7d7-3b6fa54ed7b4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number830-606RM
Company DUNS045545589
Company NameLANCER ORTHODONTICS, 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 Datefalse
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
GS100817573024179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZBHeadgear, Extraoral, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-15

Devices Manufactured by LANCER ORTHODONTICS, INC.

00817573020003 - Intrigue2018-07-06 INTRG WHISP-Z ROTH CEN +12T +5A 018 UL
00817573020010 - Intrigue2018-07-06 INTRG WHISP-Z ROTH LAT +8T +9A 018 UR
00817573020027 - Intrigue2018-07-06 INTRG WHISP-Z ROTH LAT +8T +9A 018 UL
00817573020034 - Intrigue2018-07-06 INTRG WHISP-Z ROTH CUS HK 0T +11A 018 UR
00817573020041 - Intrigue2018-07-06 INTRG WHISP-Z ROTH CUS HK 0T +11A 018 UL
00817573020058 - Intrigue2018-07-06 INTRG WHISP-Z ROTH CUS0T +11A 018 UR
00817573020065 - Intrigue2018-07-06 INTRG WHISP-Z ROTH CUS0T +11A 018 UL
00817573020072 - Intrigue2018-07-06 INTRG WHISP-Z ROTH BIC HK -7T 0A 018 UR

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