Identity
- Trade Name
- NGB-005 Needle-guided Bracket FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 0022-30-90461 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904001685 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
NGB-005 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
K102991 also covers:
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K183660 also covers:
- DP-20/30 Double probe port module — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-001 Needle-guided Bracket/DETACH — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-003 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-003 Needle-guided Bracket/DETACH — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-004 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-007 Needle-guided Bracket/STEEL — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-010 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 5c2dff09-e5c3-48a8-bd51-c15d9130ff45 34 fields · synced May 29, 2026