Identity
- Trade Name
- NGB-018 Needle-guided Bracket/VET FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 120-002055-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904086569 FDA UDI
- 510(k) Number
- K131690 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-018 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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- 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
K131690 also covers:
- 4CD4s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Display Module(M7, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Module(ANA lead/FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- IO Extend Module(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L14-6s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L7-3s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- M7 PEM(FDA, PEM-21, For UMT-200) — Shenzhen Mindray Bio-Medical Electronics Co.
- M7 Probe Extend Module(FDA, Alone) — Shenzhen Mindray Bio-Medical Electronics Co.
- M7 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-010 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- P12-4s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Power(No power cord, International) — 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 2327e310-25df-4db5-848a-0964e47223c2 34 fields · synced Jun 6, 2026