GE Ultra-Pro II Biopsy Starter Kit H40482LP

GUDID 00841436110525

Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (8.9 × 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare 4Vc transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 00841436110525
• NIH Device Record Key: e1a69cbe-b6cb-4bb6-8689-35135ebe4c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GE Ultra-Pro II Biopsy Starter Kit
• Version Model Number: H40482LP
• Catalog Number: H40482LP
• 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: false
• 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
• 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
• 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
• 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: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 Inch
• Length: 2.1 Inch
• Width: 1.5 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
• 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
• 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
• 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
• 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
• 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	00841436110525 [Primary]
GS1	20841436116361 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093713

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-08-22

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