NGB-035 Needle-guided Bracket

GUDID 06944904098487

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Ultrasound imaging system tracking holder, reusable

• Primary Device ID: 06944904098487
• NIH Device Record Key: 283e1baf-3054-4639-a78e-ce1405e4ffc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGB-035 Needle-guided Bracket
• Version Model Number: 120-005596-00
• 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	06944904098487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173471

FDA Product Code

• OIJ: Biopsy Needle Guide Kit

Sterilization

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

[06944904098487]

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Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-09-05

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