MediClear™ PreOp

GUDID 00825439012871

Antimicrobial Self-Adherent Silicone Film Drape for PreOperative Skin with Chlorhexidine and Silver

Covalon Technologies Ltd

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• Primary Device ID: 00825439012871
• NIH Device Record Key: f5ec0d15-e53d-42a7-8845-6ca57bf3bee0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediClear™ PreOp
• Version Model Number: 7000607
• Company DUNS: 206936101
• Company Name: Covalon Technologies Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: true
• OTC Over-The-Counter: true

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439012871 [Primary]
GS1	00825439012888 [Package]; Package: Carton [25 Units]; In Commercial Distribution
GS1	10825439012892 [Package]; Contains: 00825439012888; Package: Shipper [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163556

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-04-30

On-Brand Devices [MediClear™ PreOp]

• 10825439016180: Antimicrobial Self-Adherent Silicone Film Drape for PreOperative Skin with Chlorhexidine and Sil
• 00825439012871: Antimicrobial Self-Adherent Silicone Film Drape for PreOperative Skin with Chlorhexidine and Sil
• 10825439012809: Antimicrobial Self-Adherent Silicone Film Drape for PreOperative Skin with Chlorhexidine and Sil