Surgi Transducer Cover 610-217

GUDID 00841436103619

Sterile (15.2 tapered to 7.6 x 244cm) flat-folded polyethylene cover and (14 x 30cm) CIV-Flex™ cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 00841436103619
• NIH Device Record Key: 9ebaaf1e-1107-4460-a246-7e62c0277ba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgi Transducer Cover
• Version Model Number: 610-217
• Catalog Number: 610-217
• 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: true
• 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: false
• 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

Device Dimensions

• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch
• Width: 6 Inch
• Length: 96 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436103619 [Package]; Contains: 10841436103616; Package: [24 Units]; In Commercial Distribution
GS1	10841436103616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970513

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

[00841436103619]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-09-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Surgi Transducer Cover]

• 00841436101394: Sterile (15.2 tapered to 7.6 x 244cm) accordion-folded polyethylene cover and (14 x 30cm) CIV-Fl
• 00841436103947: Sterile (15.2 tapered to 7.6 x 244cm) polyethylene accordion-folded cover with large nose cone f
• 00841436103930: Sterile (15.2 tapered to 7.6 x 244cm) polyethylene accordion-folded cover with Sterile (15.2 tap
• 00841436103701: Sterile (15.2 tapered to 7.6 x 244cm) accordion-folded polyethylene (14 x 30cm) CIV-Flex™ cove
• 00841436103619: Sterile (15.2 tapered to 7.6 x 244cm) flat-folded polyethylene cover and (14 x 30cm) CIV-Flex™