Identity
- Trade Name
- NGB-040Needle-guided Bracket FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 120-004990-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904095837 FDA UDI
- 510(k) Number
- K173471 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
NGB-040Needle-guided Bracket by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasound imaging system tracking positioner, reusable.
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- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Reusable Biopsy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Reusable Multi Angle Biospy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
Cleared under the same submission
K173471 also covers:
- 4D&TEE Driver Board — Shenzhen Mindray Bio-Medical Electronics Co.
- D8-2E Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Left probe holder Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-022 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-031 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-035 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- Physio & Pen Probe Port(AHA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Right probe holder Kit — Shenzhen Mindray Bio-Medical Electronics Co.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 00460efd-de96-4ebb-a465-ad32d7bcea81 33 fields · synced Jun 1, 2026