Biopsy Starter Kit 639-051

GUDID 00841436105750

Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote IOT332 and IOT342 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking holder, reusable

• Primary Device ID: 00841436105750
• NIH Device Record Key: 4175647e-c62f-412f-abde-00e110d016e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopsy Starter Kit
• Version Model Number: 639-051
• Catalog Number: 639-051
• 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: true
• 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

Device Dimensions

• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 Inch
• Width: 1.97 Inch
• Length: 2.62 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436105750 [Primary]
GS1	20841436117535 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092619

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-08-22

On-Brand Devices [Biopsy Starter Kit]

• 00841436111652: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5), (14 × 91.5cm)
• 00841436111584: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5), (14 × 91.5cm)
• 00841436111577: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5), (14 × 147cm) C
• 00841436111225: Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
• 00841436110501: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 91.5c
• 00841436110396: Reusable non-sterile single-angle bracket with Ultra-Pro 3™ Needle guides (5), (14 x 91.5cm) C
• 00841436109505: Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex
• 00841436109420: Reusable non-sterile position sensor mount multi-angle bracket with Ultra-Pro II™ Needle guide
• 00841436109413: Reusable non-sterile position sensor mount multi-angle bracket with Ultra-Pro II™ Needle guide
• 00841436109376: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436109307: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436109222: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436109215: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5) (14 x 91.5cm) CI
• 00841436109192: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436109185: Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
• 00841436109178: Reusable non-sterile bracket with AccuSITE needle guides (5), (14 x 147cm) covers (5) for use wi
• 00841436109161: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436109154: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436109147: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436109130: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436108980: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108973: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108966: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108928: Reusable non-sterile multi-angle needle guide with cleaning brushes (5), (8.9 x 91.5cm) CIV-Flex
• 00841436108911: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (8.9 x 91.5cm)
• 00841436108812: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guide (5), (14 x 91.5cm) CI
• 00841436108799: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108782: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108744: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436108737: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108720: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108713: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108706: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108690: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108683: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C
• 00841436108652: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436108645: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 20841436117559: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436108065: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (8.9 x 91.5cm)
• 00841436108058: Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
• 00841436108034: Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
• 00841436108027: Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex
• 00841436107983: Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
• 00841436107976: Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex
• 00841436107969: Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infinit
• 00841436107952: Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex
• 00841436107945: Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 147cm) CIV-Flex
• 00841436107938: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436107921: Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm)
• 00841436107907: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) C