Positioning Arm Cover 610-946, 610-1011

GUDID 00841436101608

Sterile (25.4 tapered to 5.1 x 147cm) telescopically-folded CIV-Flex™ cover

CIVCO MEDICAL INSTRUMENTS CO., INC.

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• Primary Device ID: 00841436101608
• NIH Device Record Key: eaa630bf-6211-471c-82bb-993ca752a7b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Positioning Arm Cover
• Version Model Number: 610-946, 610-1011
• Catalog Number: 610-946, 610-1011
• 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

• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 Inch
• Length: 57.9 Inch
• Width: 10 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	00841436101608 [Package]; Contains: 10841436104552; Package: [10 Units]; In Commercial Distribution
GS1	00841436104555 [Package]; Contains: 10841436104552; Package: [24 Units]; In Commercial Distribution
GS1	10841436104552 [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

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

[00841436101608]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-06
• Device Publish Date: 2017-08-22

On-Brand Devices [Positioning Arm Cover]

• 00841436101608: Sterile (25.4 tapered to 5.1 x 147cm) telescopically-folded CIV-Flex™ cover
• 00841436104463: Sterile (25.4 tapered to 5.1 x 121.9cm) telescopically-folded CIV-Flex™ cover with Quick-Mount