DEXcam3™ Intra-oral Camera Sheaths 0.822.6921

GUDID 20618125131048

Custom fit for DEXcam3 Re-Order Dexis Part Number 0.822.5921

TIDI PRODUCTS, LLC

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• Primary Device ID: 20618125131048
• NIH Device Record Key: bfdfee86-0bde-440b-be5e-6cb4ffb54225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXcam3™ Intra-oral Camera Sheaths
• Version Model Number: 21003
• Catalog Number: 0.822.6921
• Company DUNS: 063519193
• Company Name: TIDI PRODUCTS, LLC
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618125131044 [Unit of Use]
GS1	10618125131041 [Primary]
GS1	20618125131048 [Package]; Contains: 10618125131041; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• KQM: Camera, Surgical And Accessories

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: 2023-04-21
• Device Publish Date: 2023-04-13

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