Tongue-Away Sheild

GUDID 00192029049457

Small, Medium, Large

TP ORTHODONTICS INC

Dental cheek retractor, professional, reusable

• Primary Device ID: 00192029049457
• NIH Device Record Key: 61f466a1-76e8-4662-a762-67c239f1779d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tongue-Away Sheild
• Version Model Number: 100-398
• Company DUNS: 005432299
• Company Name: TP ORTHODONTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029049457 [Primary]

FDA Product Code

• FMA: DEPRESSOR, TONGUE, NON-SURGICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-17
• Device Publish Date: 2022-05-09

On-Brand Devices [Tongue-Away Sheild]

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