POLYALL CURING LIGHT SLEEVE

GUDID D89260705533190

MAXILL, INC.

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• Primary Device ID: D89260705533190
• NIH Device Record Key: 0cfa3115-4cf1-4cb2-84b2-fe1c1f8d4981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYALL CURING LIGHT SLEEVE
• Version Model Number: 6070553319
• Company DUNS: 079343581
• Company Name: MAXILL, INC.
• Device Count: 5000
• 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: false
• 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
HIBCC	D89260705533190 [Unit of Use]
HIBCC	D89260705533191 [Primary]
HIBCC	D89260705533192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163447

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: 2022-08-01
• Device Publish Date: 2022-07-22

On-Brand Devices [POLYALL CURING LIGHT SLEEVE]

• D89260705533190: 6070553319
• D89260705533180: 6070553318