Biopsy Starter Kit DLX-200-NGB

GUDID 20841436122096

Reusable non-sterile single-angle bracket with AccuSITE™ needle guides (5) and (14 × 147cm) CIV-Flex™ covers (5), gel and bands for use with VPS Rhythm® DLX transducers (DLX-200-USP)

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable

• Primary Device ID: 20841436122096
• NIH Device Record Key: 4bfd61a7-3296-4c95-bd73-de2ab07ede54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopsy Starter Kit
• Version Model Number: DLX-200-NGB
• Catalog Number: DLX-200-NGB
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841436122054 [Primary]
GS1	20841436122096 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-29
• Device Publish Date: 2022-07-21

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