NGB-044 Needle-guided Bracket

GUDID 06936415903008

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, 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: 06936415903008
• NIH Device Record Key: 7923ddf0-1bbe-439a-879d-22d6c422d304
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGB-044 Needle-guided Bracket
• Version Model Number: 120-011966-00
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936415903008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200001

FDA Product Code

• OIJ: Biopsy Needle Guide Kit

Sterilization

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

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

[06936415903008]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-07
• Device Publish Date: 2020-11-27

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

• 06944904031408 - BC-6D Hematology Control: 2023-10-27
• 06944904031422 - BC-RET Hematology Control: 2023-10-27
• 06903053039673 - L9-3s Transducer(FDA-SJM): 2023-05-30
• 06903053039680 - P8-2Ts Transducer(FDA-SJM): 2023-05-30
• 06903053039697 - SP5-1s Transducer(FDA-SJM): 2023-05-30
• 06903053039703 - P8-2s Transducer(FDA-SJM): 2023-05-30
• 06903053039710 - CW2s Transducer(FDA-SJM): 2023-05-30
• 06903053039727 - L16-4Hs Transducer(FDA-SJM): 2023-05-30