OptiClear Sleeves

GUDID B9764488101

Disposable protective sheaths for intraoral cameras. Non-sterile. Single-use only.

Minitube AB

Medical equipment/instrument drape, single-use

• Primary Device ID: B9764488101
• NIH Device Record Key: 4c14ca56-d2f6-4060-bddd-faa1ff0bbe52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiClear Sleeves
• Version Model Number: 448806
• Company DUNS: 775295061
• Company Name: Minitube AB
• Device Count: 1000
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B9764488001 [Primary]
HIBCC	B9764488041 [Primary]
HIBCC	B9764488061 [Primary]
HIBCC	B9764488101 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211026

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: 2026-02-23
• Device Publish Date: 2026-02-13

On-Brand Devices [OptiClear Sleeves]

• B9764488081: Disposable protective sheaths for intraoral cameras. Non-sterile. Single-use only.
• B9764488101: Disposable protective sheaths for intraoral cameras. Non-sterile. Single-use only.