Identity
- Trade Name
- NGB-015 Needle-guided Bracket FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 115-002797-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904023564 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-015 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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K181637 also covers:
- L14-5WE Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-004 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-018 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-019 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-020 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-021 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-025 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 6dbfa2e9-70ed-434a-8a50-d3a6852e40b4 34 fields · synced Jun 1, 2026