Identity
- Trade Name
- NGB-020 Needle-guided Bracket/VET FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 120-002261-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904086576 FDA UDI
- 510(k) Number
- K140030 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 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
Hydrogen Peroxide FDA UDI
MR Unsafe FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
NGB-020 Needle-guided Bracket/VET 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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Cleared under the same submission
K140030 also covers:
- 2P2 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 7L4A Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW Module Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- D6-2 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- D6-2A Ultrasonic Probe (FDA) (JP) — Shenzhen Mindray Bio-Medical Electronics Co.
- D6-2A Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-N3 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Module Kit(for FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L14-6N Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-006 Needle-guided Bracket/PLAS/VET — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-006 Needle-guided Bracket/STEEL/VET — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-020 Needle-guided Bracket — 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 79afd9a0-6fed-4882-b8e9-0f8a0dc640f7 34 fields · synced Jun 1, 2026