Mindray 11364

GUDID 06975122553649

Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Mindray SV10-2U ultrasound transducers; 20g gel; 5x30cm latex cover, rubber bands.

JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Needle guide, single-use

• Primary Device ID: 06975122553649
• NIH Device Record Key: f84c15f5-5290-45b2-a2ca-e49695a1d4ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mindray
• Version Model Number: NGB-062-DK
• Catalog Number: 11364
• Company DUNS: 544571975
• Company Name: JingFang Precision Medical Device(Shenzhen) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn
• Phone: +8675527597952
• Email: Sales@innofine.cn

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975122553649 [Primary]
GS1	16975122553646 [Package]; Package: [24 Units]; In Commercial Distribution

FDA Product Code

• OIJ: Biopsy Needle Guide Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-16
• Device Publish Date: 2025-05-08

On-Brand Devices [Mindray]

• 06975122553649: Disposable Needle Guides Kit for endocavity biopsy, contents: Needle guide use with Mindray SV10
• 06975122553045: Disposable Needle Guides for use with Mindray SV10-2U Ultrasound Transducers
• 06975122553038: Reusable Needle Guides for use with Mindray LM24-6WU Ultrasound Transducers and Innofine Dispos
• 06975122553021: Reusable Needle Guides for use with Mindray SCM4-1U Ultrasound Transducers and Innofine Disposa
• 06975122553014: Reusable Needle Guides for use with Mindray LM18-4WU, LM18-5WU Ultrasound Transducers and Innof
• 06971554727344: Reusable Needle Guides for use with Mindray SC9-2U, SC10-2RCS Ultrasound Transducers and Innofi
• 06971554727320: Reusable Needle Guides for use with Mindray SCM7-1U, SC7-1U Ultrasound Transducers and Innofine
• 06971554727306: Reusable Needle Guides for use with Mindray L14-3WU, L14-3WE, L14-3Ws, L15-3WU, L13-3WE, L13-3W
• 06971554727283: Reusable Needle Guides for use with Mindray L12-3RC(s), L15-3RCs Ultrasound Transducers and Inn
• 06971554726989: Reusable Needle Guides for use with Mindray L12-3RC(s), L15-3RCs Ultrasound Transducers and Inn