Needle Guide Bracket 687-004

GUDID 20841436122775

Reusable non-sterile Infiniti Plus™ bracket for use with Terumo PS-DEZ335 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

Ultrasound imaging system tracking positioner, reusable

• Primary Device ID: 20841436122775
• NIH Device Record Key: 2df010ef-a069-4d13-8445-a11eaff52ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle Guide Bracket
• Version Model Number: 687-004
• Catalog Number: 687-004
• 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: false
• 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
• 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

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
• 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
• 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
• 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	00841436122788 [Primary]
GS1	00841436122795 [Primary]
GS1	20841436122775 [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: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [Needle Guide Bracket]

• 00841436110914: Reusable non-sterile Infiniti Plus ™ bracket for use with FUJIFILM SonoSite, Inc. C11 transduc
• 00841436109529: Reusable non-sterile single-angle bracket for use with SonoSIte L25 series transducers
• M001457100: Reusable non-sterile single-angle bracket for use with SonoSite
• 00841436107211: Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSite
• 00841436107204: Reusable non-sterile bracket for use with FUJIFILM SonoSite
• 00841436107174: Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite L25 transducers
• 00841436107167: Reusable non-sterile bracket for use with FUJIFILM SonoSite L25 transducers
• 00841436107150: Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite
• 00841436107129: Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite
• 00841436107112: Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite
• 00841436107105: Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite
• 00841436107099: Reusable non-sterile bracket for use with FUJIFILM SonoSite
• 00841436107082: Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite
• 00841436107075: Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSite
• 00841436107068: Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite
• 20841436115333: reusable non-sterile bracket for use with SonoSite L25 series transducers
• 00841436118637: Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM Sonosite L19-5 transducers
• 00841436118613: Reusable non-sterile AccuSITE™ bracket for use with FUJIFILM Sonosite L19-5 transducers
• 00841436121644: Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSITE, Inc. C10-3 transd
• 20841436122775: Reusable non-sterile Infiniti Plus™ bracket for use with Terumo PS-DEZ335 transducers
• 20841436122744: Reusable non-sterileAccuSITE™ bracket for use with Terumo PS-DEZ335 transducers
• 20841436122614: Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta MC10-3 transducers
• 20841436122584: Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta L18X transducers
• 20841436123284: Reusable non-sterile Infiniti Plus™ bracket for use with Siemens HLX transducers