System Drape 610-2380

GUDID 00841436120869

Non-sterile (76x76cm) polyethlene drape

CIVCO MEDICAL INSTRUMENTS CO., INC.

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• Primary Device ID: 00841436120869
• NIH Device Record Key: da2268ac-8e59-47ab-9344-73c6ba1519d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System Drape
• Version Model Number: 610-2380
• Catalog Number: 610-2380
• Company DUNS: 134614411
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Device Count: 1
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com
• Phone: +1(319)248-6502
• Email: regulatory@civco.com

Device Dimensions

• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter
• Width: 76 Centimeter
• Length: 76 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436120869 [Package]; Contains: 10841436120866; Package: [24 Units]; In Commercial Distribution
GS1	10841436120866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970513

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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: 2021-01-29
• Device Publish Date: 2021-01-21

On-Brand Devices [System Drape]

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• 00841436120869: Non-sterile (76x76cm) polyethlene drape
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• 00841436101417: Sterile (76 x 76cm) polyethylene drape
• 00841436110426: Sterile (81 x 91cm) polyethylene drape
• 00841436104296: Sterile polyethylene drape (81.3 x 91.4cm) for use with AccuCARE Positioning and Stabilizing equ
• 00841436104029: Sterile (11.9 tapered to 4.9 x 55.6cm) CIV-Flex™ cover for use with Mammotome EX and SenoRX En