Identity
- Trade Name
- NGB-009 Needle-guided Bracket FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 0022-30-90747 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904001661 FDA UDI
- FDA Product Code
- IYN FDA UDIOIJ FDA UDI
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 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
Hydrogen Peroxide FDA UDI
MR Unsafe FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
NGB-009 Needle-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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Cleared under the same submission
K103583 also covers:
- 4CD4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 7L4A Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
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- B/W video printer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- B/W video printer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- C5-2 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- CB10-4 Ultrasound Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-7 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-7T Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DE10-3 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Footswitch (not USB port) — Shenzhen Mindray Bio-Medical Electronics Co.
- L11-4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
K183377 also covers:
- 7L4A Ultrasonic Probe(V2.0/FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 7L4B Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- D7-2 Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-33 Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-011 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 68cd1461-0e09-427c-862b-a4f92313428a 34 fields · synced Jun 1, 2026