RED Tru-Force Latex Elastics

GUDID 00192029037515

Master Pouch 20 Cases Col-R-Lastics

TP ORTHODONTICS INC

Orthodontic inter-arch elastic band

• Primary Device ID: 00192029037515
• NIH Device Record Key: 4cdf52b6-daa7-4f81-ad0c-4a1f1e5a9e12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RED Tru-Force Latex Elastics
• Version Model Number: 372-004
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029037515 [Primary]

FDA Product Code

• ECI: BAND, ELASTIC, ORTHODONTIC

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: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [RED Tru-Force Latex Elastics]

• 00192029039724: Carton Col-R-Lastics
• 00192029037515: Master Pouch 20 Cases
• 00192029037416: Bulk Pack
• 00192029037263: Master Pouch 20 Cases
• 00192029037119: Bulk Pack