Respire Pink AT Series

GUDID 06972677870191

Modern Dental Laboratory (DG) Co., Ltd.

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device ID06972677870191
NIH Device Record Keyc413b6b5-2752-4aaa-8a64-06c1171470e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespire Pink AT Series
Version Model Number019
Company DUNS551746187
Company NameModern Dental Laboratory (DG) Co., Ltd.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972677870191 [Primary]

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


[06972677870191]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-27
Device Publish Date2022-09-19

Devices Manufactured by Modern Dental Laboratory (DG) Co., Ltd.

06972677870214 - Trioclear System 2023-09-12
06972677870221 - Trioclear System2023-09-12
06972677870238 - Trioclear System2023-09-12
06972677870207 - Orthodontic Appliance2023-08-16
06972677870191 - Respire Pink AT Series2022-09-27
06972677870191 - Respire Pink AT Series2022-09-27
06972677871877 - Respire Pink AT Series,Retainer2022-09-27
06972677871891 - Respire Pink AT Series,Splint2022-09-27
06972677870153 - Blue Series2022-09-05

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