DEXcam4™ Intra-oral Camera Sheaths 1.011.4989

GUDID 20618125155877

Custom fit for: DEXcam4 and DEXcam4HD Re-Order DEXIS Part Number 1.011.4989

TIDI PRODUCTS, LLC

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• Primary Device ID: 20618125155877
• NIH Device Record Key: cd8eaa99-f7eb-4563-9ec4-4e08eb0792b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXcam4™ Intra-oral Camera Sheaths
• Version Model Number: 21025
• Catalog Number: 1.011.4989
• 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	00618125155873 [Unit of Use]
GS1	10618125155870 [Primary]
GS1	20618125155877 [Package]; Contains: 10618125155870; 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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