MediClear™ PreOp

GUDID 10825439016180

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

Covalon Technologies Ltd

Patient surgical drape, single-use, sterile

• Primary Device ID: 10825439016180
• NIH Device Record Key: 799b82d8-df50-4f7b-b95a-f36410e6b943
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediClear™ PreOp
• Version Model Number: 7000830
• 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	00825439016169 [Primary]
GS1	00825439016176 [Package]; Contains: 00825439016169; Package: Carton [25 Units]; In Commercial Distribution
GS1	10825439016180 [Package]; Contains: 00825439016176; 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: 2018-05-18

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