Tongue-Away Sheild

GUDID 00192029049440

Medium

TP ORTHODONTICS INC

Dental cheek retractor, professional, reusable
Primary Device ID00192029049440
NIH Device Record Keya9f24383-6292-4a6a-81c6-35a0c4ba3660
Commercial Distribution StatusIn Commercial Distribution
Brand NameTongue-Away Sheild
Version Model Number100-396
Company DUNS005432299
Company NameTP ORTHODONTICS 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029049440 [Primary]

FDA Product Code

FMADEPRESSOR, TONGUE, NON-SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-17
Device Publish Date2022-05-09

On-Brand Devices [Tongue-Away Sheild]

00192029049471Shield
00192029049457Small, Medium, Large
00192029049440Medium
00192029049433Small
00192029049426Medium
00192029049419Medium
00192029049402Medium
00192029049396Medium

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