Identity
- Trade Name
- NGB-011 Needle-guided Bracket FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 0022-30-90755 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904018584 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-011 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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Also classified as Ultrasound imaging system tracking positioner, reusable.
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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.
- 7L5 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 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-009 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 2d2ccc8f-5a00-4c79-88a0-cdd5d8bbd64a 34 fields · synced May 30, 2026