Carina 570-5439

GUDID 20618125192308

Intraoral Sensor Barriers

TIDI PRODUCTS, LLC

Medical equipment/instrument drape, single-use

• Primary Device ID: 20618125192308
• NIH Device Record Key: b7d33d31-38c4-486a-908a-6bd12c848e01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carina
• Version Model Number: 570-5439
• Catalog Number: 570-5439
• Company DUNS: 063519193
• Company Name: TIDI PRODUCTS, LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618125192304 [Unit of Use]
GS1	10304040192112 [Previous]
GS1	10618125192301 [Primary]
GS1	20618125192308 [Package]; Contains: 10618125192301; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• PEM: Dental Barriers And Sleeves

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: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Carina]

• 10618125190727: Intraoral Sensor Barriers, Fits 1.5 Intraoral Sensor
• 20618125192308: Intraoral Sensor Barriers