Sirona B6310120

GUDID 20618125114669

DISPOSABLE SHEATH USBCam

TIDI PRODUCTS, LLC

Medical equipment/instrument drape, single-use

• Primary Device ID: 20618125114669
• NIH Device Record Key: c88fbe91-7431-48ac-a9a4-010aa914747d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sirona
• Version Model Number: 20809
• Catalog Number: B6310120
• Company DUNS: 063519193
• Company Name: TIDI PRODUCTS, LLC
• Device Count: 500
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618125114665 [Unit of Use]
GS1	10618125114662 [Primary]
GS1	20618125114669 [Package]; Contains: 10618125114662; Package: Case [5000 Units]; In Commercial Distribution
HIBCC	D764B63101201 [Previous]

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: 2025-07-18
• Device Publish Date: 2025-07-10

On-Brand Devices [Sirona]

• 10618125155948: XIOS XG Hygienic Covers Size 0+1
• 10618125155931: XIOS XG Hygienic Covers Size 2
• 10618125113306: X-Ray Sensor Sheaths, Sirona Sensor (1) Sheaths
• 10618125112460: X-Ray Sensor Sheaths, Sirona Sensor (2) Sheaths
• 10618125115256: Camera Cover, Fits Sirona SiroCam C
• 20618125114669: DISPOSABLE SHEATH USBCam