Optiscan 111-528

GUDID 00850024023116

Drill Cover, Cardboard Insert, Perf. Tip 8.5x175cm - 3.3"x69"

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 00850024023116
• NIH Device Record Key: d246a527-2761-4fb1-9afd-7348e206efeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optiscan
• Version Model Number: 111-528
• Catalog Number: 111-528
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00850024023109 [Primary]
GS1	00850024023116 [Package]; Contains: 00850024023109; Package: case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [Optiscan]

• 00850024023116: Drill Cover, Cardboard Insert, Perf. Tip 8.5x175cm - 3.3"x69"
• 00850031271913: Drill Cover, Cardboard Insert, Perf. Tip 8.5x50cm - 3.3"x20"